BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7119547 · Received December 14, 2017

    Report

    Report Number
    0001825034-2017-11024
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    August 17, 2017
    Report Date
    May 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND TOOL MARKS, SCRATCHING, AND YELLOWISH DEBRIS ON THE INNER RADIUS. THE DEBRIS ON THE INNER RADIUS IS CONSISTENT WITH THE LARGE AMOUNT OF DEBRIS ON THE OUTER RADIUS AND LIKELY TRANSFERRED DUE TO BEING STORED WITHIN THE DECONTAMINATION BAG. A PORTION OF THE POROUS COATING HAS CHIPPED AWAY FROM THE OUTER RADIUS OF THE CUP. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TAPERLOC POR LAT FMRL 9X137 LOT#230200 ITEM# 11-103203, M2A-MAGNUM 42-50 TPR INSRT STD LOT#507230 ITEM#139256, M2A-MAGNUM PF CUP 50ODX44ID ITEM#US157850 LOT#212390. LEGAL COUNSEL . THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. NOTES FROM THE LEGAL NOTIFICATION SUGGEST THAT THE PATIENT HAS UNDERWENT A REVISION DUE TO LOCAL TISSUE REACTION AND A LARGE PSEUDOCYST. THE NOTES ALSO NOTED A LARGE CYSTIC MASS WITH YELLOWISH-BROWN CASEATING LINING THAT WAS VERY FRIABLE. THE CUP AND THE HEAD WERE REVISED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-11004.

    Description of Event or Problem · 1

    REVISION DUE TO LOCAL TISSUE REACTION AND A PSEUDOCYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897543 M2A-MAGNUM MOD HD SZ 44MM HIP, PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 505500

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10