MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-24 for REF THREE HOLE SHELL 50MM 71336450 manufactured by Smith & Nephew, Inc..
[177211166]
It was reported that during a thr surgery, the doctor prepared acetabulum and took a trial of cup size 50. It was good and fixed well so he took the original reflection shell and it fixed well. He then put a 25mm screw for better fixation, then fixed liner for 32 mm head. Later he prepared the femur fix stem and took trial for the head and reduced the hip joint. When he dislocated the hip to put the original head reflection shell, the liner came out and the screw remained inside the bone (it was later removed). He tried to fix it again but did not succeed and then he took size 54 mm. This caused a delay of 30 minutes to an hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04587 |
| MDR Report Key | 9517163 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-24 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2019-12-24 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REF THREE HOLE SHELL 50MM |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
| Product Code | MBL |
| Date Received | 2019-12-24 |
| Model Number | 71336450 |
| Catalog Number | 71336450 |
| Lot Number | 19HM06387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-24 |