FDA Adverse Event
Injury
Summary report: N
ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK
MDR report key: 2232461
·
Received August 25, 2011
Report
- Report Number
- 9616680-2011-00555
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- April 11, 2007
- Report Date
- August 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K023901
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBER AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 625-0T-32F, LOT # 625-0T-32F, DESCRIPTION: TRIDENT ALUMINA INSERT.
Description of Event or Problem · 1
LETTER RECEIVED FROM A PATIENT REGARDING AN EVENT WHERE HE STATED THAT LEFT HIP REVISION SURGERY TO REPLACE ACETABULAR CERAMIC BEARING AS A RESULT OF 8 MONTHS OF HIP SQUEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 9274002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |