BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 7065970 · Received November 28, 2017

    Report

    Report Number
    0001825034-2017-10570
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    June 1, 2017
    Report Date
    July 16, 2020
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED AND THE COMPLAINT SAMPLE EVALUATED. UPON VISUAL INSPECTION, THE MODULAR HEAD APPEARED TO HAVE THE STEM STUCK INSIDE AND COULD NOT BE REMOVED. THE OUTER RADIUS OF THE HEAD SHOWED SCUFFING AND INDENTATIONS AND THE CUP SHOWED SCUFFING ON THE INNER RADIUS WITH NO DAMAGE TO THE OUTSIDE RADIUS. THE ROOT CAUSE REMAINS UNCHANGED WITH THE INFORMATION 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 MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 10569, 0001825034 - 2017 - 10570. CONCOMITANT MEDICAL PRODUCTS: US157858 M2A-MAGNUM PF CUP 58ODX52ID LOT 954320, 157452 M2A-MAGNUM MOD HD SZ 52MM LOT 050220, 120002 COCR TROCH CABLE 2.0MMX750MM LOT 899690,  120005 COCR CABLE SLEEVE 2.0MM LOT 274300,  X21-180312 HA BIMETRIC/X POR NC STD 12MM LOT 899900, 139266 M2A-MAGNUM 52-60MM TPR INSRT-3 LOT 922870. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO PAIN, WEAR, INSTABILITY, ELEVATED IONS AND DISLOCATION. ALL COMPONENTS WERE REVISED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843481 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 050220

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R