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 2020-03-27 for BIPOLAR PROSTHESIS 43/28 75004360 manufactured by Smith & Nephew Orthopaedics Ag.
[187023610]
It was reported that during a hemi-hip replacement using a bipolar prosthesis. The poly liner was brought out during the removal of the retaining ring, which made the bipolar prosthesis unusable. A smaller size prosthesis was used to complete the surgery. No delay was reported and no extra cuts were performed due to downsizing the prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613369-2020-00074 |
| MDR Report Key | 9891974 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | OBERNEUHOFSTRASSE 10D |
| Manufacturer City | BAAR |
| Manufacturer Country | SZ |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR PROSTHESIS 43/28 |
| Generic Name | PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED |
| Product Code | KWY |
| Date Received | 2020-03-27 |
| Catalog Number | 75004360 |
| Lot Number | B1804388 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Address | OBERNEUHOFSTRASSE 10D BAAR 06340 SZ 06340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |