OFFSET TIB TRAY 2.5MM ADAPTOR
Received Nov 21, 2012 · Event occurred Nov 13, 2012
Report 0001825034-2012-02430 · MDR key 2842557
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141490
Lot number
485010
Product problems
- Positioning Problem
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY PROCEDURE UTILIZING AN OFFSET TIBIA TRAY ADAPTOR ON (B)(6) 2012. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO FIT THE ADAPTOR INTO THE ADAPTOR HANDLE. ANOTHER OFFSET TIBIA TRAY ADAPTOR WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, A THIRTY MINUTE DELAY OCCURRED AS A RESULT.
Additional Manufacturer Narrative
EVALUATION OF ANOTHER 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