OFFSET TIB TRAY 2.5MM ADAPTOR
Received Nov 21, 2012 · Event occurred Oct 30, 2012
Report 0001825034-2012-02432 · MDR key 2841941
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141490
Lot number
378330
Product problems
- Fitting Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION PROCEDURE REMOVING COMPETITOR PARTS ON (B)(6) 2012. DURING THE PROCEDURE, THE OFFSET TIBIA TRAY ADAPTOR DID NOT FIT WITH THE ADAPTOR HANDLE. ANOTHER OFFSET TIBIA TRAY ADAPTOR WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY. THERE WAS NO INJURY TO THE PATIENT 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