FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 41487
·
Received October 1, 1996
Report
- Report Number
- 33141-1996-00021
- Event Type
- Injury
- Date Received
- October 1, 1996
- Date of Event
- September 26, 1996
- Report Date
- September 27, 1996
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTG
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A 00-5220-012-00. THE PATELLA WAS A WHITE POROUS IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | MG PATELLA | HTG | ZIMMER, INC. | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |