BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7591757 · Received June 12, 2018

    Report

    Report Number
    0001825034-2018-03846
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    January 16, 2018
    Report Date
    October 14, 2021
    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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6   THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED FOUND SCRATCHING AND SCUFFING ON THE OUTER RADIUS OF THE HEAD. TOOL IMPRESSIONS WERE ALSO LEFT ON THE SIDE OF THE HEAD. THE HEAD REMAINS ASSEMBLED WITH THE TAPER INSERT. VISUAL INSPECTION OF THE TAPER INSERT IDENTIFIED SCRATCHING ACROSS THE EXPOSED SURFACE WITH DAMAGE TO THE CIRCULAR CUT OUTS. WHITE DEBRIS IS PRESENT WITHIN THE TAPER OF THE INSERT. THE TAPER INSERT REMAINS ASSEMBLED WITH THE HEAD. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF PREVIOUS INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. 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 # US157850, CUP, LOT # 768230, ITEM # 139254, TAPER INSERT, LOT # 719830, ITEM # 11-103205, FEMORAL STEM, LOT # 881230. LEGAL NOTIFICATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO METALLOSIS, WEAR DEBRIS, AND PAIN. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO METALLOSIS CAUSED BE WEAR DEBRIS, PAIN, AND ELEVATED ION LEVELS. IT WAS NOTED IN THE OPERATIVE NOTES THAT UPON ENTRY, THERE WAS EXTRUDED A SIGNIFICANT AMOUNT OF UNUSUALLY GREENISH-YELLOW COLORED FLUID THAT WAS CLEAR AND NO PURULENT-APPEARING. METALLOSIS LIKE TISSUE WAS NOTED. ACETABULAR AND FEMORAL COMPONENTS WERE STABLE AND NO EVIDENCE OF LOOSENING. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435698 M2A-MAGNUM MOD HD SZ 44MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 843220

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R