FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 146516
·
Received January 28, 1998
Report
- Report Number
- 33141-1998-00008
- Event Type
- Injury
- Date Received
- January 28, 1998
- Date of Event
- January 27, 1998
- Report Date
- January 28, 1998
- 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
THE PT NOTICED A SQUEAKING NOISE IN HIS KNEE. IT WAS FOUND THAT THE PLASTIC HAD WORN THROUGH TO THE METAL. THE MG I PATELLA WAS REPLACED WITH A 00-5220-014-00, LOT # 14053900. THE MG I PATELLA WAS A WHITE POROUS IMPLANT. THE HOSP RELEASED THE DEVICE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | MG PATELLA | HTG | ZIMMER, INC. | NA | 67207800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |