FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - HIP IMPLANT
MDR report key: 1113181
·
Received August 12, 2008
Report
- Report Number
- 9616680-2008-00238
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, 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 THE PATIENT STATED THAT FOR THE PAST THREE MONTHS, HE HAS BEEN EXPERIENCED SQUEAKING AND ALSO PAIN ON HIS LEFT HIP. HE STATED THAT THE SQUEAKING IS MORE PROMINENT WHEN HE GOES UP THE STAIRS OR LIFTS SOMETHING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - HIP IMPLANT | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |