FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 149580
·
Received February 16, 1998
Report
- Report Number
- 33141-1998-00014
- Event Type
- Injury
- Date Received
- February 16, 1998
- Date of Event
- February 13, 1998
- Report Date
- February 13, 1998
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- 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 WORN THROUGH TO THE METAL BACK. THE MG I PATELLA WAS REPLACED WITH A 00-5220-012-11. LOT # 14520600. THE MG I PATELLA WAS A BLACK POROUS IMPLANT. THE HOSP DISCARDED THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | MG PATELLA | JWH | ZIMMER, INC. | NA | 564639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |