MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-05 for UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM manufactured by Depuy Orthopaedics Inc Us.
[188899731]
Product complaint # (b)(4). Occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188899732]
Pcf and medical records received. After review of medical records, patient was revised to address adverse local tissue reaction with metallosis after right total hip arthroplasty with significant lysis and greater trochanteric fracture along with pseudotumor. Operative notes stated that radiographs showed osteolysis and lucency under acetabular shell as well as elevated esr and crp. An aspiration of the hip revealed white blood cell count greater than 6000 as well as a left shift. A ct scan showed possibility of pseudotumor and elevated cobalt and chromium levels. Incision was made laterally, dissected down to the iliotibial band to gluteus medius vastus lateralis and found obvious greater trochanteric fracture that was comminuted as well as loss of the calcar when the stem was examined. There was a tremendous amount of metal stained tissue. The bone also appeared stained with metal debris. When the head was removed, the trunnion was exposed with significant amount of metal oasis. Attention was in acetabular component, significant amount of anteversion was noted. There was a large area of pseudotumor and was excised. There was also a fluid on the hip. There was a significant erosion of the acetabulum with loss of mainly the anterior wall. No indication of infection. There was significant amount of posterior impingement noted and the trunnion of the femoral stem had been impinge posteriorly on the cup for many years. Doi: (b)(6) 2008 - dor: (b)(6) 2018; right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-06917 |
| MDR Report Key | 9792957 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-18 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HIP FEMORAL STEM |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KXA |
| Date Received | 2020-03-05 |
| Catalog Number | UNK HIP FEMORAL STEM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |