FDA Adverse Event
Injury
Summary report: N
KINMX PLUS, SML TIB B/PL ASSY
MDR report key: 771373
·
Received October 18, 2006
Report
- Report Number
- 9610726-2006-00057
- Event Type
- Injury
- Date Received
- October 18, 2006
- Date of Event
- June 8, 2006
- Report Date
- September 27, 2006
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
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 ON SEPTEMBER 25, 2006 THAT THE BASEPLATE HAD FRACTURED AND THE INSERT WAS LOOSE. PATIENT WAS REVISED THE FOLLOWING MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINMX PLUS, SML TIB B/PL ASSY | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LPBTJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |