FDA Adverse Event
Injury
Summary report: N
ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK
MDR report key: 1132050
·
Received August 21, 2008
Report
- Report Number
- 9616680-2008-00251
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K023901
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT 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 THE PT HAD A RECURRENT DISLOCATING LEFT TOTAL HIP. THE COMPONENTS WERE IMPLANTED AT HOSPITAL IN 2005, ALONG WITH AN ACCOLADE TMZF HIP STEM #3 6020-0335. THE IMPLANTS WITH THE EXCEPTION OF THE HIP STEM WERE EXPLANTED DUE TO RECURRENT DISLOCATION THE FOLLOWING YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |