FDA Adverse Event
Malfunction
Summary report: N
APEX-LNK POLY ACETABULAR CUP LINERS
MDR report key: 2463065
·
Received February 13, 2012
Report
- Report Number
- 1226188-2012-00004
- Event Type
- Malfunction
- Date Received
- February 13, 2012
- Report Date
- April 29, 2010
- Manufacturer
- OMNILIFE SCIENCE INC.
- Product Code
- LPH
- PMA / PMN Number
- K073150
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED ACETABULAR INSERT WAS EVALUATED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. THE ACETABULAR INSERT HAD NO OBVIOUS INCONSISTENCIES. THE PROBLEM COULD NOT BE REPRODUCED WITH THE RETURNED ACETABULAR INSERT.
Description of Event or Problem · 1
THE SURGEON EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO SEAT THE APEX-LNK ACETABULAR INSERT INTO THE ACETABULAR SHELL. THERE WAS AN APPROXIMATELY 10 MIN DELAY IN THE SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX-LNK POLY ACETABULAR CUP LINERS | HIP-JOINT, SEMI-CONSTRAINED, UNCEMENTED | LPH | OMNILIFE SCIENCE INC. | 6175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |