BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 7475153 · Received May 1, 2018

    Report

    Report Number
    0001825034-2018-02996
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    March 31, 2017
    Report Date
    March 6, 2019
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES. DEVICE HISTORY RECORD (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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST-OP DUE TO METAL ON METAL COMPLICATIONS INCLUDING PAIN, DISLOCATION, METALLOSIS, LOOSENING, LACK OF MOBILITY, AND INFECTION. . DURING THE PROCEDURE, IT WAS NOTED THAT TRUNNIONOSIS WAS ON THE FEMORAL NECK AND TROCHANTERIC BURSITIS WAS IDENTIFIED. A TROCHANTERIC BURSECTOMY WAS PERFORMED. PAIN WAS ALSO POSSIBLY LINKED TO THE IDENTIFIED BURSITIS THAT WAS IDENTIFIED.

    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, DUE TO UNKNOWN PRODUCT LOCATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORT SOURCE, CONSUMER - ATTORNEY. CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A-MAGNUM MOD HD SZ 50 MM ITEM# 157450, LOT#: 203060. BIOMET M2A-MAGNUM 42-50 M TPR INSRT +6 ITEM#: 139260, LOT#: 808000. BIOMET TAPERLOC POR FMRL LAT 13.5X147 ITEM#: 11-103207, LOT#: 305410. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02998.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST-OP DUE TO METAL ON METAL COMPLICATIONS INCLUDING PAIN, DISLOCATION, METALLOSIS, LOOSENING, LACK OF MOBILITY, AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319592 M2A-MAGNUM PF CUP 56ODX50ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 495280

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R