MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for PROSTHESIS, HIP, CONSTRAINED, METAL manufactured by .
[112157961]
History of present illness: male patient who presents with complaints of right hip pain. He was involved in a motorcycle accident when he was a teenager and suffered a right hip fracture for which he underwent open reduction internal fixation and subsequently developed an infection. He then underwent a total hip arthroplasty and has since had multiple revisions, primarily of the socket. His last revision was over 15 years ago, and was a revision of his acetabular component. A few months ago, procedure in detail: hip was dislocated and head ball was removed from the femoral component capsulectomy was then performed to allow for mobilization. The polyethylene liner was then removed from the cup and the screws were removed. Several of the screws had broken. Cup was then removed from the acetabulum. Anterior and posterior columns were intact. There is no pelvic discontinuity. There was certainly breach of the medial wall. Broken screw removal set was used to remove the broken screws that were visible within the cup from the acetabulum. Curette was used to remove fibrous soft tissue and polyethylene debris from the acetabulum. Pathology gross description: the specimen is received fresh, submitted as "total joint explants right hip" and consists of a 6. 5 x 6. 5 x 3. 0 cm gray metallic acetabulum with two fractured silver-gray, metallic screws. The acetabulum contains a 6. 2 x 5. 8 by up to 1. 5 cm white plastic liner received in the same container is a 3. 8 x 2. 6 x 2. 6 cm silver metallic prosthetic femoral head. Received in the same container are two threaded fractured metallic screws that average 1. 5 x 0. 7 cm. No sections are submitted. The specimen is for gross diagnosis only.
Patient Sequence No: 1, Text Type: D, B5
[112187795]
History of present illness: male patient who presents with complaints of right hip pain. He was involved in a motorcycle accident when he was a teenager and suffered a right hip fracture for which he underwent open reduction internal fixation and subsequently developed an infection. He then underwent a total hip arthroplasty and has since had multiple revisions, primarily of the socket. His last revision was over 15 years ago, and was a revision of his acetabular component. A few months ago, procedure in detail: hip was dislocated and head ball was removed from the femoral component capsulectomy was then performed to allow for mobilization. The polyethylene liner was then removed from the cup and the screws were removed. Several of the screws had broken. Cup was then removed from the acetabulum. Anterior and posterior columns were intact. There is no pelvic discontinuity. There was certainly breach of the medial wall. Broken screw removal set was used to remove the broken screws that were visible within the cup from the acetabulum. Curette was used to remove fibrous soft tissue and polyethylene debris from the acetabulum... Pathology gross description the specimen is received fresh, submitted as "total joint explants right hip" and consists of a 6. 5 x 6. 5 x 3. 0 cm gray metallic acetabulum with two fractured silver-gray, metallic screws. The acetabulum contains a 6. 2 x 5. 8 by up to 1. 5 cm white plastic liner received in the same container is a 3. 8 x 2. 6 x 2. 6 cm silver metallic prosthetic femoral head. Received in the same container are two threaded fractured metallic screws that average 1. 5 x 0. 7 cm. No sections are submitted. The specimen is for gross diagnosis only.
Patient Sequence No: 1, Text Type: D, B5
[112188292]
History of present illness: male patient who presents with complaints of right hip pain. He was involved in a motorcycle accident when he was a teenager and suffered a right hip fracture for which he underwent open reduction internal fixation and subsequently developed an infection. He then underwent a total hip arthroplasty and has since had multiple revisions, primarily of the socket. His last revision was over 15 years ago, and was a revision of his acetabular component. A few months ago, procedure in detail: hip was dislocated and head ball was removed from the femoral component capsulectomy was then performed to allow for mobilization. The polyethylene liner was then removed from the cup and the screws were removed. Several of the screws had broken. Cup was then removed from the acetabulum. Anterior and posterior columns were intact. There is no pelvic discontinuity. There was certainly breach of the medial wall. Broken screw removal set was used to remove the broken screws that were visible within the cup from the acetabulum. Curette was used to remove fibrous soft tissue and polyethylene debris from the acetabulum... Pathology gross description the specimen is received fresh, submitted as "total joint explants right hip" and consists of a 6. 5 x 6. 5 x 3. 0 cm gray metallic acetabulum with two fractured silver-gray, metallic screws. The acetabulum contains a 6. 2 x 5. 8 by up to 1. 5 cm white plastic liner received in the same container is a 3. 8 x 2. 6 x 2. 6 cm silver metallic prosthetic femoral head. Received in the same container are two threaded fractured metallic screws that average 1. 5 x 0. 7 cm. No sections are submitted. The specimen is for gross diagnosis only.
Patient Sequence No: 1, Text Type: D, B5
[112188500]
History of present illness: male patient who presents with complaints of right hip pain. He was involved in a motorcycle accident when he was a teenager and suffered a right hip fracture for which he underwent open reduction internal fixation and subsequently developed an infection. He then underwent a total hip arthroplasty and has since had multiple revisions, primarily of the socket. His last revision was over 15 years ago, and was a revision of his acetabular component. A few months ago, procedure in detail: hip was dislocated and head ball was removed from the femoral component capsulectomy was then performed to allow for mobilization. The polyethylene liner was then removed from the cup and the screws were removed. Several of the screws had broken. Cup was then removed from the acetabulum. Anterior and posterior columns were intact. There is no pelvic discontinuity. There was certainly breach of the medial wall. Broken screw removal set was used to remove the broken screws that were visible within the cup from the acetabulum. Curette was used to remove fibrous soft tissue and polyethylene debris from the acetabulum... Pathology gross description the specimen is received fresh, submitted as "total joint explants right hip" and consists of a 6. 5 x 6. 5 x 3. 0 cm gray metallic acetabulum with two fractured silver-gray, metallic screws. The acetabulum contains a 6. 2 x 5. 8 by up to 1. 5 cm white plastic liner received in the same container is a 3. 8 x 2. 6 x 2. 6 cm silver metallic prosthetic femoral head. Received in the same container are two threaded fractured metallic screws that average 1. 5 x 0. 7 cm. No sections are submitted. The specimen is for gross diagnosis only.
Patient Sequence No: 1, Text Type: D, B5
[112188699]
History of present illness: male patient who presents with complaints of right hip pain. He was involved in a motorcycle accident when he was a teenager and suffered a right hip fracture for which he underwent open reduction internal fixation and subsequently developed an infection. He then underwent a total hip arthroplasty and has since had multiple revisions, primarily of the socket. His last revision was over 15 years ago, and was a revision of his acetabular component. A few months ago, procedure in detail: hip was dislocated and head ball was removed from the femoral component capsulectomy was then performed to allow for mobilization. The polyethylene liner was then removed from the cup and the screws were removed. Several of the screws had broken. Cup was then removed from the acetabulum. Anterior and posterior columns were intact. There is no pelvic discontinuity. There was certainly breach of the medial wall. Broken screw removal set was used to remove the broken screws that were visible within the cup from the acetabulum. Curette was used to remove fibrous soft tissue and polyethylene debris from the acetabulum... Pathology gross description the specimen is received fresh, submitted as "total joint explants right hip" and consists of a 6. 5 x 6. 5 x 3. 0 cm gray metallic acetabulum with two fractured silver-gray, metallic screws. The acetabulum contains a 6. 2 x 5. 8 by up to 1. 5 cm white plastic liner received in the same container is a 3. 8 x 2. 6 x 2. 6 cm silver metallic prosthetic femoral head. Received in the same container are two threaded fractured metallic screws that average 1. 5 x 0. 7 cm. No sections are submitted. The specimen is for gross diagnosis only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7632336 |
| MDR Report Key | 7632336 |
| Date Received | 2018-06-22 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-07-31 |
| Date Reported to Mfgr | 2017-09-26 |
| Date Added to Maude | 2018-06-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | PROSTHESIS, HIP, CONSTRAINED, METAL |
| Product Code | KXD |
| Date Received | 2018-06-22 |
| Device Availability | Y |
| Device Age | 5840 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-22 |