FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER HIP IMPLANT
MDR report key: 2161164
·
Received July 8, 2011
Report
- Report Number
- 9616680-2011-00464
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- October 1, 2010
- Report Date
- June 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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
VOLUN (B)(6)-2011: A MONTH AFTER HAVING HIP REPLACEMENT SURGERY WITH A STRYKER HIP IMPLANT, HAVE STARTED HAVING TROUBLE WITH IT. SQUEAKING NOISE WHEN WALKING. CAN'T HARDLY STAND UP AND IN EXTREME PAIN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRYKER HIP IMPLANT | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |