FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 871980
·
Received June 25, 2007
Report
- Report Number
- 1226188-2007-00006
- Event Type
- Injury
- Date Received
- June 25, 2007
- Date of Event
- June 5, 2007
- Report Date
- June 22, 2007
- Manufacturer
- OMNILIFE SCIENCE INC.
- Product Code
- KWY
- PMA / PMN Number
- K000788
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OTHER DEVICES USED: CATALOG NUMBER 220610 APEX MODULAR LONG 50 NECK. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION. RADIOGRAPHS PROVIDED BY INITIAL REPORTER INDICATE SHEAR FAILURE OF THE FEMORAL STEM COBALT CHROMIUM ALIGNMENT PIN.
Description of Event or Problem · 1
POROUS FEMORAL STEM REVISED 31 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. PRIOR TO REVISION, PATIENT COMPLAINED OF POSSIBLE HIP DISLOCATION AND PAIN. RADIOGRAPHS REVEALED ROTATION OF THE MODULAR NECK. DURING REVISION SURGEON NOTED FAILURE OF THE FEMORAL STEM ALIGNMENT PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNILIFE SCIENCE INC. | 6X14.5 STEM | 553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |