BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7361815 · Received March 22, 2018

    Report

    Report Number
    0001825034-2018-02106
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    March 29, 2016
    Report Date
    February 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVISION OP NOTES CONFIRM THAT THE PATIENT UNDERWENT A RIGHT HIP REPLACEMENT ON (B)(6) 2016, DURING THE PROCEDURE THE SURGEON NOTED A LOOSENED ACETABULAR COMPONENT WAS FOUND MIGRATED MEDIALLY BEYOND THE MEDIAL WALL OF THE PELVIS AND LOOSENED, THE MEDIAL DEFECT WAS PACKED WITH CANCELLOUS CHIPS THAT WERE OBTAINED FROM 2 FEMORAL HEAD ALLOGRAFTS, ADDITIONALLY, THE HIP WAS DISLOCATED. INDICATIONS ALSO MENTIONED SHORTENING AND A LIMP. THE PATIENT WAS NEGATIVE FOR INFECTION. DEVICE HISTORY RECORD (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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157850, M2A-MAGNUM PF CUP 50ODX44ID, 088040, 11-103205, TAPERLOC POR LAT FMRL 11X142, 405500, 139256, M2A MAGNUM TPR ADPR TI DIA42-5 0/0MMT1, 222650. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02107. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT¿S LEGAL COUNSEL REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATIENT ALLEGATIONS OF PAIN AND POSSIBLE PSEUDOTUMOR SECONDARY TO THE METAL-ON-METAL BEARINGS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. PATIENT WAS REVISED APPROXIMATELY 7 YEARS AFTER THE INITIAL SURGERY DUE TO PAIN, ALLERGIC REACTION, LIMB LENGTH DISCREPANCY, DISLOCATION, LOOSENING OF THE ACETABULAR CUP, BONE LOSS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205943 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 043710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R