BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 7536908 · Received May 23, 2018

    Report

    Report Number
    0001825034-2018-03295
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    March 7, 2016
    Report Date
    February 13, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVISION SURGERY'S OP-NOTES CONFIRMED THE PRESENCE OF ADVERSE TISSUE REACTION AND PSEUDOTUMOR. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED APPROX 6 YEARS POST OP DUE TO PAIN, ADVERSE LOCAL TISSUE RESPONSE, PSEUDOTUMOR, AND ELEVATED METAL IONS. DURING REVISION, SIGNIFICANT THICK AND DARK COLORED FLUID, PSEUDOCAPSULE, COLD WELDED TRUNNION TO STEM, ACETABULAR MEDIAL AND POSTERIOR WALL DEFECT AND LARGE BONY PEDESTAL ENCOUNTERED ON THE FEMUR WERE NOTED. NO ADDITIONAL INFORMATION WAS AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED BY SALES DIRECTOR STATING REVISION PROCEDURE MAY NOT HAVE OCCURRED. CONCOMITANT MEDICAL PRODUCTS: X180311, BI-METRIC/X POR NC 11X135, 036650, 139259, M2A MAGNUM 42-50M TPR INSRT +6, 070130, US157852, M2A-MAGNUM PF CUP 52ODX46ID, 163560. 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 - 03293, 0001825034 - 2018 - 03294, 0001825034 - 2018 - 03292. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379127 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 634780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R