FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 211884
·
Received February 26, 1999
Report
- Report Number
- 1822565-1999-00008
- Event Type
- Injury
- Date Received
- February 26, 1999
- Date of Event
- January 26, 1998
- Report Date
- January 28, 1999
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEVICES WERE IMPLANTED ON 02/03/1996. FOLLOWING PERSISTENT PAIN AND SWELLING, KNEE WAS REVISED ON 01/26/1998 WHERE FRAGMENTS OF POLYETHYLENE WERE NOTED TO BE WITHIN THE JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | MG II KNEE 10MM PATELLAR | HTG | ZIMMER, INC. | NA | 11569900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |