BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD

    MDR report key: 1873073 · Received October 18, 2010

    Report

    Report Number
    1825034-2010-00431
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY RESPONDED TO BIOMET AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6) 2010 WITH EVENT DETAILS. THE RISK MANAGER AT THE USER FACILITY CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AND RELAYED THAT THEY WOULD NOT BE FILING A MEDWATCH TO REPORT THE EVENT. REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT HAD NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED OCTOBER 18, 2010.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE FOUND SCRATCHES AND WEAR MARKS TYPICALLY SEEN ON CUP INSERTERS. THE BLACK SILICONE HANDLE IS WELL ATTACHED TO THE METAL. THE LOCK FUNCTIONS WITH THE REAR GEAR AS INTENDED. BOTH GEAR SHAFTS ROTATE EASILY, HOWEVER, WHEN THE REAR GEAR IS ROTATED, THE FROND GEAR DOES NOT ROTATE. WHEN THE REAR GEAR IS UNLOCKED AND THE GEARS REMOVED, IT CAN BE SEEN THAT THE REAR GEAR TEETH HAVE BEEN SHEARED OFF. THE FRACTURE SURFACE ARTIFACTS SUGGEST AN OVERLOAD FRACTURE WITH MULTIPLE ORIGINS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP PROCEDURE UTILIZING AN ACETABULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, AFTER THE SURGEON IMPACTED THE CUP, HE TRIED TO UNTHREAD THE CUP FROM THE INSERTER AND REALIZED THE CUP WAS SPINNING ON THE INSERTER. THE CUP WAS REMOVED AND INSPECTION OF THE INSERTER REVEALED THAT THE TEETH WERE MISSING FROM THE GEARS OF THE UPPER INSERTER ARM. THE SURGEON FOUND FRAGMENTS OF THE TEETH WITHIN THE WOUND SITE AND REMOVED THEM. THE ACETABULAR CUP WAS REINSERTED UTILIZING A DIFFERENT INSERTER AND NO DELAY IN SURGERY OR PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP PROCEDURE UTILIZING AN ACETABULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, AFTER THE SURGEON IMPACTED THE CUP, HE TRIED TO UNTHREAD THE CUP FROM THE INSERTER AND REALIZED THE CUP WAS SPINNING ON THE INSERTER. THE CUP WAS REMOVED AND INSPECTION OF THE INSERTER REVEALED THAT THE TEETH WERE MISSING FROM THE GEARS OF THE UPPER INSERTER ARM. THE SURGEON FOUND FRAGMENTS OF THE TEETH WITHIN THE WOUND SITE AND REMOVED THEM. THE ACETABULAR CUP WAS REINSERTED UTILIZING A DIFFERENT INSERTER AND NO DELAY IN SURGERY OR PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD ORTHO, MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 240880

    Patients

    Seq Age Sex Outcome Treatment
    1