BIOMET OFFSET TIBIAL TRAY ADAPTOR
Received Mar 3, 2009 · Event occurred Jan 21, 2009
Report 1825034-2009-00038 · MDR key 1328284
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet Inc.Model number
N/ACatalog number
141491
Lot number
644290
Product problems
- Component Incompatible
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
EXPIRATION DATE - CORRECTED TO REFLECT 12/31/2018
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A 5.0MM BIOMET OFFSET TIBIAL TRAY ADAPTOR IN EARLY 2009. THE LOCKING INSERT THAT WAS INCLUDED IN THE PACKAGE WAS THE WRONG SIZE AND WOULD NOT FIT WITH THE 5.0MM ADAPTOR. ANOTHER 5.0MM ADAPTOR WAS AVAILABLE AND THE APPROPRIATE SIZED LOCKING INSERT WAS RETRIEVED FROM THAT PACKAGE.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A 5.0MM BIOMET OFFSET TIBIAL TRAY ADAPTOR IN 2009. THE LOCKING INSERT THAT WAS INCLUDED IN THE PACKAGE WAS THE WRONG SIZE AND WOULD NOT FIT WITH THE 5.0MM ADAPTOR. ANOTHER 5.0MM ADAPTOR WAS AVAILABLE AND THE APPROPRIATE SIZED LOCKING INSERT WAS RETRIEVED FROM THAT PACKAGE.
Additional Manufacturer Narrative
OTHER - VISUAL EXAMINATION OF RETURNED COMPONENT IDENTIFIED THAT THE INCORRECT SIZED INSERT WAS PACKAGED WITH THIS ADAPTOR. RECALL WAS INITIATED TO RECOVER PRODUCT. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.
Remedial action
- Recall