FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 110752
·
Received August 2, 1997
Report
- Report Number
- 33141-1997-00002
- Event Type
- Injury
- Date Received
- August 2, 1997
- Date of Event
- July 22, 1997
- Report Date
- August 1, 1997
- 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 MG I PATELLA WAS REPLACED WITH A 00-5110-067-41. THE MG I PATELLA WAS A BLACK POROUS IMPLANT. THE HOSPITAL DISCARDED THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | MG PATELLA | HTG | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |