FDA Adverse Event
Injury
Summary report: N
ZIMMER, INC.
MDR report key: 1133446
·
Received June 12, 2008
Report
- Report Number
- 1133446
- Event Type
- Injury
- Date Received
- June 12, 2008
- Date of Event
- May 14, 2008
- Report Date
- June 10, 2008
- Manufacturer
- ZIMMER
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SURGEON REPORTS PT REQUIRED (L) HIP REVISION DUE TO LOOSENING OF (L) HIP PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER, INC. | HIP PROSTHESIS - SHELL | KWA | ZIMMER | 2320673 | ||
| 2 | ZIMMER, INC. | HIP PROSTHESIS - HEAD | KWY | ZIMMER | 2325668 | ||
| 3 | ZIMMER, INC. | HIP PROSTHESIS - LINER | KWB | ZIMMER | 2337024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |