FDA Adverse Event
Malfunction
Summary report: N
MODULAR MICROPLASTY CUP INSERTER
MDR report key: 1001651
·
Received February 18, 2008
Report
- Report Number
- 1825034-2008-00061
- Event Type
- Malfunction
- Date Received
- February 18, 2008
- Date of Event
- January 22, 2008
- Report Date
- January 23, 2008
- Manufacturer
- BIOMET, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- 2008-001R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. OTHER - EVAL OF RETURNED DEVICE FOUND EVIDENCE THAT THE INSTRUMENT FRACTURED AT A LASER WELD AS A RESULT OF VIBRATION. IT WAS FURTHER IDENTIFIED THAT THE WELD WAS BRITTLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2008. DURING PROCEDURE, INSTRUMENT BROKE AND A SMALL METAL RING FELL IN THE PT. SURGEON REMOVED THE RING AND POST-OP RADIOGRAPHS FOUND NO EVIDENCE OF FOREIGN OBJECT RETENTION OF PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODULAR MICROPLASTY CUP INSERTER | LXH | BIOMET, INC. | NA | 095116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |