FDA Adverse Event
Injury
Summary report: N
UNKNOWN TRIATHLON PRIMARY FEMUR
MDR report key: 2070925
·
Received April 19, 2011
Report
- Report Number
- 2249697-2011-00516
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE(S) WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2011-00515.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT WAS IN A CAR ACCIDENT WHICH NECESSITATED A REVISION AND THE SURGEON USED DEPUY REPLACEMENTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN TRIATHLON PRIMARY FEMUR | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |