BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 8377983 · Received February 28, 2019

    Report

    Report Number
    0001825034-2019-00493
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    July 25, 2018
    Report Date
    August 22, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES NOTING METALLOSIS OF THE LEFT HIP. A LARGE AMOUNT OF FLUID AND PARTICULATE MATTER WAS FOUND ALONG WITH BLACK COLORED SYNOVIUM THAT APPEAR TO BE PSEUDOCYSTS THROUGHOUT THE JOINT. THE CUP COMPONENT WAS FOUND TO BE LOOSE AND COATED WITH BLACK MATERIAL ON THE BACKSIDE. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-103203 ¿ STEM ¿ 042650, 139252 ¿ INSERT ¿ 907300, US157850 ¿ CUP ¿ 644600. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00492.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO FAILED METAL ON METAL CONSTRUCT WITH MULTIPLE ADVERSE SYMPTOMS. DURING THE PROCEDURE, FLUID OF METALLOSIS WAS NOTED ALONG WITH A LARGE AMOUNT OF FLUID AND PARTICULATE MATTER. THERE WAS BLACK-COLORED SYNOVIUM THAT APPEARED TO BE PSEUDOCYSTS THROUGHOUT THE JOINT FOUND ALONG WITH A LARGE CONTINUATION OF THE PSEUDOCYST IN THE LARGE BURSA. THE CUP COMPONENT WAS FOUND TO BE LOOSE WITH THE ENTIRE BACK COATED WITH BLACK MATERIAL INTO THE BONE AND SYNOVIUM. THE TROCHANTER WAS NOTED TO HAVE NECROSIS ALONG WITH SUSTAINING AN INTRAOPERATIVE FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO PAIN, TISSUE AND BONE DESTRUCTION, METAL POISONING, AND LIMITATION OF DAILY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171385 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 742780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R