FDA Adverse Event
Malfunction
Summary report: N
BIOMET ARCOM AP PATELLA 3-PEG
MDR report key: 1052091
·
Received May 20, 2008
Report
- Report Number
- 1825034-2008-00145
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- September 13, 2007
- Report Date
- October 15, 2007
- Manufacturer
- BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- K921182
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF RETURNED DEVICE FOUND IMPLANT DID NOT MEET DESIGN SPECIFICATIONS. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENT AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY PROCEDURE IN 2007, THE PEG ORIENTATION OF THE PATELLA BUTTON DID NOT MATCH THE DRILL GUIDE ORIENTATION. ADD'L 11-150844 COMPONENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET ARCOM AP PATELLA 3-PEG | JWH | BIOMET, INC. | NA | 534650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |