BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 7769373 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-04286
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    November 16, 2016
    Report Date
    March 21, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION RECEIVED OF THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. THIS INFORMATION DOES NOT CHANGE THE PREVIOUSLY SUBMITTED INVESTIGATION RESULTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION RECEIVED, THE PATIENT UNDERWENT A REVISION DUE TO PAIN AND LOOSENING ELEVATED ION LEVELS, BONE FRACTURE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 04285 . CONCOMITANT PRODUCTS: 139256 M2A-MAGNUM 42-50 TPR INSRT STD, LOT 221610; US157856 M2A-MAGNUM PF CUP 56ODX50ID, LOT 510970; X11-170313 INTEGRAL LOT 397330. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, AND ELEVATED ION LEVELS. REVISION SURGEON REPORTED METAL-ON-METAL ARTICULATION AND ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611479 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 744450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R