BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIH MOD CUP INSERTER

    MDR report key: 3981650 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06832
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS EVALUATED AND A VISUAL EXAMINATION OF THE DAMAGED /CHIPPED TEETH ON THE REAR GEAR AND THE INSERTER SCREW INDICATED THAT THE PART HAD BEEN USED EXTENSIVELY. THERE WAS A BLUE FOREIGN SUBSTANCE ON THE REAR GEAR. THE THREAD OF THE INSERTER SCREW WAS FOUND TO MEET SPECIFICATIONS. IT APPEARS THAT ONCE THE INSERTER ENGAGED THE CUP AND A LOAD WAS APPLIED, THAT THE DAMAGED/CHIPPED TEETH AND THE BLUE FOREIGN SUBSTANCE MAY HAVE CONTRIBUTED TO THE IMPROPER FUNCTION OF THE INSERTER.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. MANUFACTURE DATE ¿ UNKNOWN. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06831 / 06832).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE INSERTER THREADS WOULD NOT DISENGAGE FROM THE ACETABULAR CUP. THE ACETABULAR CUP AND INSERTER WERE REMOVED AND ANOTHER ACETABULAR CUP AND INSERTER WERE UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457372 MIH MOD CUP INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A ZB120501

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention