BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIH MOD CUP INSERTER

    MDR report key: 6801926 · Received August 17, 2017

    Report

    Report Number
    0001825034-2017-06467
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    November 21, 2016
    Report Date
    May 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE CUP WAS ABLE TO BE FREED FROM THE INSERTER. VISUAL INSPECTION OF THE INSERTER SHOWS SIGNS OF WEAR AND TEAR OVER A SERVICE LIFETIME OF APPROXIMATELY 4 YEARS. THE FRONT GEAR IS FRACTURED AND HAS TWO GEARS/ TEETH MISSING. THE SQUARE END OF THE INSERTER HAS SOME DEBRIS ON IT WHERE IT WAS JOINED TO THE CUP; ONCE SEPARATED, THERE IS SOME EVIDENCE OF CORROSION IN THE THREADS. SEM ANALYSIS OF THE FRACTURED SURFACES OF THE FRONT GEAR OF THE INSERTER INDICATED THE FRACTURE OCCURRED DUE TO BRITTLE OVERLOAD. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REGEN/RNGLC+ LTD 56MM SZ 24 CATALOG#: PT-116056 LOT#: K070369. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-05242. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHELL WAS IMPLANTED AND THE SURGEON COULD NOT FREE THE SHELL INSERTER FROM THE SHELL AS IT WAS COLD WELDED INTO THE SHELL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581697 MIH MOD CUP INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A ZB130401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other