BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 8206309 · Received December 31, 2018

    Report

    Report Number
    0001825034-2018-11522
    Event Type
    Injury
    Date Received
    December 31, 2018
    Date of Event
    April 24, 2018
    Report Date
    April 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K833175
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCUFFING AND SCRATCHING ON THE OUTER RADIUS OF THE HEAD. GOUGES AND DINGS ARE PRESENT ON THE RIM. THE TAPER INSERT WAS ALSO RETURNED. THE EXPOSED FACE IS DINGED AND DEFORMED. LIGHT DEBRIS IS PRESENT INSIDE THE TAPER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # US257856, MAGNUM TRISPIKE CUP, LOT # 264460; ITEM #139252, M2A-MAGNUM 42-50MM TPR INSRT-6, LOT # 920510; ITEM #11-10421, MLRY-HD LAT POR FMRL, LOT # 303380.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO METALLOSIS, ELEVATED ION LEVELS, ALTR AND OSTEOLYSIS. OPERATIVE NOTES INDICATED: UPON ENTERING THE FASCIA LATA, THE PATIENT DID HAVE SOME METALLOSIS ON HIS TISSUES; THEY WERE DEBRIDED; REACTIVE TISSUE IN THE HIP AT THIS TIME AS WELL. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046266 M2A-MAGNUM MOD HD SZ 50MM HIP PROSTHESIS KWY ZIMMER BIOMET, INC. N/A 563840

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10.