MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-20 for UNK manufactured by Unk.
[50212]
Pt had a right ankle replacement approx 10 years ago. Last year she began developing pain and swelling. The ankle implant was removed during surgery on 2/20/97. During surgery it was discovered that the talar component along with the polyethylene component were loose. The medial part of the talus was totally disintegrated and a large amount of metal debris and polyethylene wear was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 78532 |
| MDR Report Key | 78532 |
| Date Received | 1997-03-20 |
| Date of Report | 1997-03-18 |
| Date of Event | 1997-02-20 |
| Date Facility Aware | 1997-02-20 |
| Report Date | 1997-03-18 |
| Date Reported to FDA | 1997-03-18 |
| Date Added to Maude | 1997-03-27 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | KXC |
| Date Received | 1997-03-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 78153 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-03-20 |