MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for DF-80 FEMORAL STEM/ZIMMER ACETABULAR DF-80 STEM 14.5MM 45 HIGH ZIMMER ACETABULAR CUP (28 manufactured by Zimmer Manufacturing Copany.
[10329]
Patient had history of left total hip arthrolasty in august, 1983. Patient has had recent anterior thigh pain with ambulation. Revision of left total hip on 1/27/94 revealed loosened acetabular cu and worn femoral head. Black metallic staining of soft tissue in the joint was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17660 |
| MDR Report Key | 17660 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-02-02 |
| Date of Event | 1994-01-27 |
| Date Facility Aware | 1994-01-27 |
| Report Date | 1994-02-02 |
| Date Added to Maude | 1994-11-15 |
| 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 |
| 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 | DF-80 FEMORAL STEM/ZIMMER ACETABULAR |
| Generic Name | CUP |
| Product Code | JDD |
| Date Received | 1994-07-29 |
| Model Number | DF-80 STEM 14.5MM 45 HIGH |
| Catalog Number | ZIMMER ACETABULAR CUP (28 |
| Lot Number | D-F80 STEM - 694834 |
| ID Number | ACETABULAR CUP - 004469 |
| Device Availability | N |
| Device Age | 10 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17577 |
| Manufacturer | ZIMMER MANUFACTURING COPANY |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-07-29 |