BIOMET OFFSET TIBIAL TRAY ADAPTOR 5.0MM
Received Mar 16, 2009 · Event occurred Feb 16, 2009
Report 1825034-2009-00056 · MDR key 1343458
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141491
Lot number
644290
Product problems
- Inadequacy of Device Shape and/or Size
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY IN 2009, THE SCRUB NURSE TRIED PUTTING TOGETHER THE OFFSET ADAPTOR WITH THE STEM, BUT THE SCREW IN THE STEM WOULD NOT ENGAGE WITH THE LOCKING INSERT. A 2.5MM LOCKING INSERT WAS PACKAGED WITH THE 5MM ADAPTOR. AN ADDITIONAL COMPONENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DELAY IN THE PROCEDURE WAS APPROXIMATELY FIFTEEN MINUTES.
Additional Manufacturer Narrative
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.
Remedial action
- Recall