FDA Adverse Event
Injury
Summary report: N
NEXGEN STEMMED TIBIAL COMPONENT
MDR report key: 2031159
·
Received March 22, 2011
Report
- Report Number
- 1822565-2011-00703
- Event Type
- Injury
- Date Received
- March 22, 2011
- Date of Event
- December 2, 2002
- Report Date
- February 23, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: WITHOUT ADD'L INFO, THE CAUSE OF LOOSENING CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPEC. VISUAL INSPECTION OF THE TIBIAL PLATE SHOWS NO PMMA ON THE INFERIOR SURFACE. THERE IS DAMAGE TO THREE OF THE POLY PLUGS. THERE ARE SCRATCHES ON THE SUPERIOR SURFACE INDICATIVE OF THIRD BODY PARTICLES BEING CAUGHT IN BETWEEN THE ART SURFACE AND THE TIBIAL PLATE DURING MOTION. ALL MEASUREMENTS TAKEN WERE FOUND TO BE WITHIN SPECS.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN STEMMED TIBIAL COMPONENT | JWH | ZIMMER, INC. | 60346937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |