InjuryBWN
SIGNATURE KNEE GUIDES 04-05
Received Oct 28, 2011
Report 0001825034-2011-00952 · MDR key 2313007
Device
Generic name
Surgical Guide
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
42-422461
Lot number
004408
Product problems
- Failure to Align
- Malposition of Device
Patient
Not reported
- Limited Mobility Of The Implanted Joint
Narrative
Description of Event or Problem
PATIENT REPORTED TO HAVE UNDERGONE TOTAL KNEE ARTHROPLASTY ON (B)(6), 2009 AND ALLEGES LOSS OF FUNCTION OF HIS KNEE DUE TO MISALIGNED, ILL POSITIONED KNEE IMPLANT. A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00949 / 00952).