FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PRODUCT - LEFT HIP
MDR report key: 1121227
·
Received August 15, 2008
Report
- Report Number
- 9616680-2008-00246
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 30, 2008
- Report Date
- July 30, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT IS EXPERIENCING SQUEAKING WHEN HE BENDS DOWN. PATIENT STATED THAT HE HAS BEEN TO THE DOCTOR AND AN XRAY HAS SHOWN THAT THERE IS NO PROBLEMS WITH THE IMPLANT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - LEFT HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |