FDA Adverse Event
Injury
Summary report: N
ACCOLADE TMZF HIP STEM #4
MDR report key: 1971502
·
Received January 20, 2011
Report
- Report Number
- 9616680-2011-00027
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 5, 2011
- Manufacturer
- STRYKER ORTHOAPEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "AN INITIAL F/U PT COMPLAINED OF PAIN, SUBSEQUENT XRAYS REVEALED A FEMORAL FRACTURE. DURING REVISION SURGERY, ALL ORIGINAL IMPLANTS WERE REMOVED. IT IS UNK WHETHER FEMORAL FRACTURE OCCURRED INTRAOPERATIVELY DURING PRIMARY SURGERY OR SOMETIMES POST-OPERATIVELY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE TMZF HIP STEM #4 | IMPLANT | MEH | STRYKER ORTHOAPEDICS CORK | NA | 32886803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |