FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT- 32MM V40 ALUMIN CERAMIC HEAD
MDR report key: 1163121
·
Received September 16, 2008
Report
- Report Number
- 9616680-2008-00282
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 29, 2008
- Report Date
- August 29, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, 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 MFR. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT COMPLAINED OF AUDIBLE SQUEAK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT- 32MM V40 ALUMIN CERAMIC HEAD | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |