FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 217003
·
Received March 29, 1999
Report
- Report Number
- 1822565-1999-00031
- Event Type
- Injury
- Date Received
- March 29, 1999
- Date of Event
- August 14, 1998
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
TWO YEARS AND 7 MONTHS POST-OP DEVICE LOOSENED REQUIRING REVISON SURGERY TO REMOVE AND REPLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | CENTRALIGN 2.5 FEM STEM | KWY | ZIMMER, INC. | NA | 71750900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |