MalfunctionMBV
BIOMET OFFSET TIB TRAY 2.5MM ADAPTOR
Received Nov 21, 2012 · Event occurred Sep 18, 2012
Report 0001825034-2012-02361 · MDR key 2842448
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141490
Lot number
378320
Product problems
- Nonstandard Device
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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).
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A REVISION KNEE PROCEDURE OF UNKNOWN PRODUCT ON (B)(6) 2012 UTILIZING AN OFFSET ADAPTOR. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO USE THE ADAPTOR WITH THE HANDLE. ANOTHER ADAPTOR WAS USED TO FINISH THE PROCEDURE.
Remedial action
- Recall