BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A HI CARBON MODULAR HEAD

    MDR report key: 6328543 · Received February 14, 2017

    Report

    Report Number
    0001825034-2017-00390
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 16, 2017
    Report Date
    April 18, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: 11-163679 28MM M2A HI CARBON HD +3MM NK 902340; 15-105011 M2A TPR HI CARBON 37/28MM LNR 841770; 103531 TI LOW PROFILE SCREW 6.5X20MM 845130; 103531 TI LOW PROFILE SCREW 6.5X20MM 845150; 10-104050 M2A-T M/H RAD 2HL SHL 37/50MM 587360; X11-180440 BI METRIC/XR LAT RPP C/L 10MM 607080. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEDICATED IMAGES 9 YEARS AFTER PRIMARY OPERATION OF THE RIGHT HIP CONFIRMS A ZONE OF LUCENCY SURROUNDING THE ACETABULAR SCREWS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2017-00390 &1825034-2017-00391).

    Description of Event or Problem · 1

    PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY 10 YEARS POST-IMPLANTATION DUE TO PAIN AND EVIDENCE OF A PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112455 M2A HI CARBON MODULAR HEAD HIP PROSTHESIS KWA BIOMET ORTHOPEDICS N/A 902340

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R