FDA Adverse Event
Injury
Summary report: N
WRIGHT MEDICAL TECHNOLOGIES SIZE 52MM LINEAGE SOLID ACETABULAR COMPONENT
MDR report key: 2922371
·
Received January 14, 2013
Report
- Report Number
- MW5028650
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- June 7, 2005
- Report Date
- January 10, 2013
- Manufacturer
- WRIGHT MEDICAL
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
MAN WITH END STAGE ARTHROSIS OF THE RIGHT HIP UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. THE HIP STEM BROKE 7 YEARS LATER REQUIRING SURGICAL REVISION. WRIGHT MEDICAL TECHNOLOGIES SIZE 52MM LINEAGE SOLID ACETABULAR COMPONENT WITH A GROUP II 32MM ID ALUMINA CERAMIC ACETABULAR LINER AND A PROFEMUR S ALPHA SIZE 16 FEMORAL COMPONENT WITH A LONG VARUS NECK AND A 32X+3.5 FEMORAL HEAD COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20773 | WRIGHT MEDICAL TECHNOLOGIES SIZE 52MM LINEAGE SOLID ACETABULAR COMPONENT | ARTIFICIAL HIP IMPLANT- ACETABULAR COMPONENT | KWA | WRIGHT MEDICAL | |||
| 20774 | WRIGHT MEDICAL TECHNOLOGIES GROUP II 32MM ID ALUMINA CERAMIC ACETABULAR LINER | ARTIFICIAL HIP IMPLANT- ACETABULAR LINER | LZO | WRIGHT MEDICAL | |||
| 20893 | WRIGHT MEDICAL TECHNOLOGIES PROFEMUR S ALPHA SIZE 16 FEMORAL COMPONENT W LONG VA | ARTIFICIAL HIP IMPLANT - FEMORAL COMPONENT | KWA | WRIGHT MEDICAL | |||
| 20894 | WRIGHT MEDICAL TECHNOLOGIES 32X + 3.5 FEMORAL HEAD COMPONENT | ARTIFICIAL HIP IMPLANT- FEMORAL HEAD | LZO | WRIGHT MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |