FDA Adverse Event
Injury
Summary report: N
UNKNOWN HIP IMPLANT
MDR report key: 1160467
·
Received September 12, 2008
Report
- Report Number
- 9616680-2008-00272
- Event Type
- Injury
- Date Received
- September 12, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- 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, "PT STATED THAT HAS BEEN EXPERIENCING A LOUD SQUEAKING NOISE AND PAIN FROM LEFT HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN HIP IMPLANT | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |