BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ML/HD RNGLC FINN ACET HAP 52MM

    MDR report key: 5718509 · Received June 10, 2016

    Report

    Report Number
    3002806535-2016-00352
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 12, 2016
    Report Date
    July 12, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, THE LOCKING RING SHOWED EVIDENCE OF BEING MISSHAPEN. HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS AND PRECAUTIONS, NUMBER 3 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." NUMBER 4 STATES, "MALALIGNMENT OF COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE."

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

    Description of Event or Problem · 1

    DURING A TOTAL HIP ARTHROPLASTY, THE LOCKING RING ON THE ACETABULAR CUP BECAME DETACHED AFTER IMPACTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACETABULAR CUP. THERE WAS NO DELAY IN THE PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371624 ML/HD RNGLC FINN ACET HAP 52MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3590256

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention