FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #3
MDR report key: 1881109
·
Received October 20, 2010
Report
- Report Number
- 9616680-2010-00652
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K023102
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. ADDITIONAL 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 BY THE PT, "PT IS HAVING PAIN IN HER HIP ALL THE TIME. EVERY TIME SHE GOES TO DO SOMETHING OR TWIST THE WRONG WAY, SHE FEELS A LOT OF PAIN AND IS ON BED REST FOR A FEW DAYS. PT BELIEVES HER HIP WAS PART OF THE RECALL. DOCTORS HAVE HER ON VICODIN 4 TIMES A DAY FOR PAIN. HER HIP REPLACEMENT WAS ON HER LEFT SIDE BUT THE PAIN IS SO SEVERE SHE ALSO FEELS THE PAIN ON HER RIGHT SIDE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM #3 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 13383302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |