BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 8061596 · Received November 12, 2018

    Report

    Report Number
    0001825034-2018-10567
    Event Type
    Injury
    Date Received
    November 12, 2018
    Date of Event
    January 10, 2018
    Report Date
    January 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM # (B)(4), M2A-MAGNUM MOD HD, LOT # 861830; ITEM # (B)(4), M2A-MAGNUM 42-50MM TPR INSRT, LOT # 933320; ITEM # (B)(4), TAPERLOC POR FMRL, LOT # 841460.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT BEGAN HAVING AN ACHE IN THE LEFT HIP. SUBSEQUENTLY THE PATIENT WAS REVISED 11 YEARS POST IMPLANTATION DUE TO ALLEGATIONS OF PAIN, METALLOSIS, AND ELEVATED ION LEVELS. OPERATIVE NOTES INDICATED DEFICIENT TISSUE POSTERIORLY AND BULGING FLUID FROM THE HIP JOINT WHICH APPEARED DISCOLORED. THERE WAS METAL STAINING IN THE CAVITY. AFTER REMOVING THE CUP, IT WAS NOTED THAT THERE WAS SOME DELAMINATION OF THE POROUS COATING THAT REMAINED SECURELY ATTACHED TO THE BONE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, HIP-MOM-HEADS-UNK, LOT # UNK; ITEM # UNK, HIP-UNKNOWN-STEMS-UNK, LOT # UNK. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10566, 0001825034-2018-10567, 0001825034-2018-10568.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (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 · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED FOR UNKNOWN REASONS AN UNKNOWN TIMEFRAME POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902323 M2A-MAGNUM PF CUP 48ODX42ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 613920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R