BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL SHELL WITH MULTI-HOLES

    MDR report key: 2060959 · Received March 14, 2011

    Report

    Report Number
    1822565-2011-00570
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    September 7, 2009
    Report Date
    September 9, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE BACKSIDE OF THE SHELL THERE ARE AREAS AROUND CERTAIN SCREW HOLES WHICH ARE DAMAGED. IT APPEARS AS IF THE TM HAS BEEN COMPRESSED OR REMOVED AROUND THE EDGES OF THESE SCREW HOLES. THIS TYPE OF MARKING COULD BE CAUSED BY ATTEMPTS TO INSERT A SCREW AT AN EXTREME ANGLE. IT IS POSSIBLE THAT THE PILOT HOLE WAS DRILLED FOR THESE SCREW HOLES WITHOUT USING A DRILL GUIDE, OR WITH THE DRILL GUIDE NOT INSERTED INTO THE SCREW HOLE, WHICH WOULD ALLOW FOR EXTREME ANGULATION. IT IS POSSIBLE THAT THE SCREWS WERE EXCESSIVELY TIGHTENED, CAUSING THE SCREW HEAD TO BREAK THROUGH THE TM. IT IS UNKNOWN WHICH SCREW HOLES WERE USED DURING SURGERY. SURGICAL NOTES WERE NOT RETURNED AND IT IS THEREFORE IMPOSSIBLE TO DETERMINE IF THE SURGICAL TECHNIQUE WAS FOLLOWED. GIVEN THE UNCERTAINTY ABOUT THE USE OF THE DEVICES, IT IS IMPOSSIBLE TO DEFINITIVELY DETERMINE THE CAUSE OF FAILURE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER IMPACTING THE SHELL AND INSERTING THE SCREWS INTO THE SHELL, THE SURGEON REMOVED THE SHELL AND SCREWS AND INDICATED HE FELT ONE OF THE SCREWS HAD GONE THROUGH THE SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL SHELL WITH MULTI-HOLES JDI ZIMMER, INC. 60043184

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW: CATALOG #00625006540, LOT#61175929| ALL MANUFACTURED AT ZIMMER (B)(4)| BONE SCREW: CATALOG #00625006525, LOT# 61173040| BONE SCREW: CATALOG #00625006530, LOT# 61246409