BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD ACETABULAR SHELL 54MM POROUS + HAP COATED

    MDR report key: 6090920 · Received November 9, 2016

    Report

    Report Number
    3002806535-2016-00828
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 7, 2016
    Report Date
    March 30, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET UK AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K030055.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE RETURNED SHELL WAS CHECKED FOR DAMAGE. EXTERNAL SOILING DAMAGE WAS FOUND ON THE SHELL HOWEVER, THIS WAS DUE TO THE IMPLANT BEING IMPLANTED IN THE PATIENT AND THEN EXPLANTED. THERE WAS NO DAMAGE TO THE LOCKING RING AND LOCKING RING WAS PRESENT IN THE SHELL. ONLY OBSERVATION THAT CAN BE DETERMINED WAS THAT THE RING WAS OVERLAPPING HOWEVER, THE DISPOSITION OF THE RING DUE TO THE SURGEON STATING THAT HE HAD TO REFIT THE RING CANNOT BE DETERMINED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 1

    DURING AN INITIAL LEFT HIP ARTHROPLASTY, THE LOCKING RING CAME OUT OF THE SHELL DURING IMPACTION OF THE SHELL. ANOTHER SHELL WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741650 MALLORY-HEAD ACETABULAR SHELL 54MM POROUS + HAP COATED PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3585564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention