FDA Adverse Event
Injury
Summary report: N
CITATION TMZF HA STEM #6 LEFT
MDR report key: 2090895
·
Received May 12, 2011
Report
- Report Number
- 9616680-2011-00299
- Event Type
- Injury
- Date Received
- May 12, 2011
- Date of Event
- April 8, 2010
- Report Date
- April 26, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K936127
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 THAT, "THE PT HAS THIGH AND GROIN PAIN. PT IS HAVING TROUBLE WALKING. PT HAS TO WEAR VERY CUSHIONY SHOES TO HELP HER WALK/STANDING. THE LEFT IMPLANT PAIN IS MUCH MORE PRONOUNCED AFTER HAVING THE RIGHT HIP REPLACED. THE PT WANTS TO KNOW IF HER IMPLANTS WERE PART OF A RECALL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CITATION TMZF HA STEM #6 LEFT | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 28697801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |