FDA Adverse Event
Injury
Summary report: N
TRIATHLON-SYMMETRIC PATELLA S27MM X 8MM
MDR report key: 2010638
·
Received February 24, 2011
Report
- Report Number
- 9610726-2011-00050
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- February 9, 2011
- Report Date
- February 9, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "TRAUMATIC FALL CAUSED THE PATELLA TO FRACTURE. IMPLANT WAS INTACT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-SYMMETRIC PATELLA S27MM X 8MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LAX713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |