FDA Adverse Event
Injury
Summary report: N
SHORT TIBIA BEARING COMPONENT
MDR report key: 1822777
·
Received August 30, 2010
Report
- Report Number
- 9610726-2010-00270
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- December 29, 2009
- Report Date
- August 14, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON REPLACED THE BUSHINGS AND BEARING COMPONENTS OF THE KRH FEMUR BUT THEN DECIDED TO CONVERT THE KRH INTO A DISTAL FEMUR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHORT TIBIA BEARING COMPONENT | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |