FDA Adverse Event
Injury
Summary report: N
KX+DURAT LS INSERT SM 12MM
MDR report key: 767153
·
Received October 2, 2006
Report
- Report Number
- 9610726-2006-00052
- Event Type
- Injury
- Date Received
- October 2, 2006
- Date of Event
- September 11, 2006
- Report Date
- September 11, 2006
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT MANUFACTURED IN THE US. EVALUATION OF THIS DEVICE IS TO BE PERFORMED AT THE MANUFACTURING FACILITY. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSERT HAD TO BE REVISED AFTER FOUR YEARS BECAUSE OF HEAVY WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KX+DURAT LS INSERT SM 12MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |