FDA Adverse Event
Injury
Summary report: N
DURA DURATION ALL POLY PAT LG
MDR report key: 2042103
·
Received March 30, 2011
Report
- Report Number
- 9616680-2011-00154
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JWH
- PMA / PMN Number
- K910235
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.# 9616680-2011-00153.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WORN INSERT AND PATELLA REQUIRED REVISION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURA DURATION ALL POLY PAT LG | IMPLANT | JWH | STRYKER ORTHOPAEDICS CORK | NA | VWUWA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |