FDA Adverse Event
Malfunction
Summary report: N
APEX HIP SYSTEM
MDR report key: 2809629
·
Received October 25, 2012
Report
- Report Number
- 1226188-2012-00062
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- July 16, 2012
- Report Date
- October 25, 2012
- Manufacturer
- OMNILIFE SCIENCE, INC.
- Product Code
- KWB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE RETURNED INSTRUMENT CONFIRMS THAT THE THREADS ARE DAMAGED AT VERY TIP (BURRS PRESENT AS WELL AS DENTS PRESENT).
Description of Event or Problem · 1
THE THREADS ON THE IMPACTOR ARE WORN OUT DURING IMPACTION AND CANNOT THREAD INTO A CUP. NO HARM TO PT. NO DELAY IN THE SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX HIP SYSTEM | ACETABULAR IMPACTOR | KWB | OMNILIFE SCIENCE, INC. | C1006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |