FDA Adverse Event
Malfunction
Summary report: N
APEX HIP SYSTEM
MDR report key: 2809630
·
Received October 25, 2012
Report
- Report Number
- 1226188-2012-00063
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- July 25, 2012
- Report Date
- October 23, 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 AND DENTS PRESENT). IN ADDITION, THE WELD BETWEEN SHAFT AND TIP HAS CRACKED.
Description of Event or Problem · 1
THE THREADS ON THE IMPACTOR ARE WORN OUT DURING IMPACTION AND CANNOT THREAD INTO A CUP. WELD IS ALSO BROKEN. 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 | 67 YR |