MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for REDAPT 71354757 manufactured by Smith Nephew, Inc..
[183507264]
This is another case for this patient who developed another peri prosthetic fracture. Patient was doing well with physical therapy using a walker at home as needed. He returned to md office 2 months post-surgery with complaints of pain at right hip area. X-ray completed in office and reveals a fracture of the plate and revision surgery was scheduled 4 days later. During this or procedure, the femoral component of the original surgery was replaced with a new smith and nephew fracture plate implanted and would cultures were done. Wound culture were negative. Device information: synthes plate (noted in emr as "plate fem prox ss lcp" 4. 5mm 10h 283mm lgth rt).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9834930 |
| MDR Report Key | 9834930 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-10 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | REDAPT |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS |
| Product Code | KTW |
| Date Received | 2020-03-16 |
| Model Number | 71354757 |
| Catalog Number | 71354757 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH NEPHEW, INC. |
| Manufacturer Address | 1303 GOSHEN PKWY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |