FDA Adverse Event
Malfunction
Summary report: N
LINEAGE(R) DURAMER(R) ACETABULAR LINER
MDR report key: 3850663
·
Received June 5, 2014
Report
- Report Number
- 3010536692-2014-00887
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 15, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Description of Event or Problem · 1
ALLEGEDLY DURING THE SURGERY, THE LINER WAS LOOSE WHEN SET INTO THE ACETABULAR SHELL WHICH COULD NOT BE MATCHED. BACKUP DEVICE WAS AVAILABLE. SURGERY TIME EXTENDED GREATER THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329584 | LINEAGE(R) DURAMER(R) ACETABULAR LINER | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | 1538482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |