FDA Adverse Event
Malfunction
Summary report: N
APEX-LNK POLY ACETABULAR CUP LINERS
MDR report key: 2520699
·
Received April 4, 2012
Report
- Report Number
- 1226188-2012-00024
- Event Type
- Malfunction
- Date Received
- April 4, 2012
- Date of Event
- February 17, 2012
- Report Date
- March 8, 2012
- Manufacturer
- OMNLIFE SCIENCE, INC.
- Product Code
- LPH
- PMA / PMN Number
- K073150
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED APEX-LNK ACETABULAR INSERT WAS EVALUATED AND FOUND TO BE WITHIN MFG SPECIFICATIONS. THE PROBLEM COULD NOT BE REPRODUCED WITH THE RETURNED APEX-LNK 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. THE PT WAS NOT HARMED BY THE EVENT. THERE WAS A 10 TO 12 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-CONTRAINED, UNCEMENTED | LPH | OMNLIFE SCIENCE, INC. | 10511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |