OFFSET TIB TRAY 2.5MM ADAPTOR
Received Nov 20, 2012 · Event occurred Aug 30, 2012
Report 0001825034-2012-02431 · MDR key 2840828
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141490
Lot number
378330
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2012 TO REMOVE SPACERS THAT WERE PLACED DUE TO INFECTION. DURING THE PROCEDURE, THE OFFSET TIBIAL TRAY ADAPTOR WOULD NOT ENGAGE. ANOTHER TIBIAL TRAY ADAPTOR WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT INJURY TO THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AS A RESULT.
Additional Manufacturer Narrative
EVALUATION OF RETURNED DEVICE CONFIRMED REPORTED CONDITION. DECISION WAS MADE TO RECALL BASED ON AN OPERATOR ISSUE THAT WAS DETERMINED AS PART OF AN INTERNAL INVESTIGATION. (B)(4).
Remedial action
- Recall