BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TAPER

    MDR report key: 7440760 · Received April 18, 2018

    Report

    Report Number
    0001825034-2018-02850
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    January 16, 2017
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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. 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

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. INITIAL REPORTER - NI. (B)(6). CONCOMITANT MEDICAL PRODUCTS: 11-163679 28 MM M2A HI CARBON HD +3 MM NK 902340, 15-105011 M2A TPR HI CARBON 37/28 MM LNR 841770, 103531 TI LOW PROFILE SCREW 6.5 X 20 MM 845130, 103531 TI LOW PROFILE SCREW 6.5 X 20 MM 845150, 10-104050 M2A-T M/H RAD 2HL SHL 37/50 MM 587360, X11-180440 BI METRIC/XR LAT RPP C/L 10 MM 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.

    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
    281792 M2A TAPER HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 587360

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R