BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 7935401 · Received October 4, 2018

    Report

    Report Number
    0001825034-2018-09379
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    April 3, 2017
    Report Date
    January 15, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO ELEVATED ION LEVELS, DIFFICULTY AMBULATING, PAIN AND METALLOSIS. OPERATIVE NOTES REPORT STAINED SYNOVIUM WITH EXTENSIVE AMOUNTS OF SYNOVITIS AND GRAY DEBRIS IN THE INTRARTICULAR SPACE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. MEDICAL DEVICES: ITEM NUMBER: US257858, ITEM NAME: MAGNUM TRISPIKE CUP 58ODX52ID, LOT #: 778300; ITEM NUMBER: 103206, ITEM NAME: TAPERLOC POR FMRL 12.5X145, LOT #: 606120; ITEM NUMBER: 139264, ITEM NAME: M2A-MAGNUM 52-60MM TPR INSRT-6, LOT #: 072870. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09378. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE REPORTS. REVISION OPERATIVE NOTES WERE REVIEWED AND IT WAS IDENTIFIED PATIENT WAS REVISED DUE FAILED MOM CONSTRUCT. THE PATIENT HAS HAD GRAYLY STAINED SYNOVIUM, EXTENSIVE AMOUNT OF SYNOVITIS AND GREY DEBRIS IN THE INTRAARTICULAR SPACE CONSISTENT WITH METALLOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED DUE TO ELEVATED ION LEVELS, PAIN, METALLOSIS, AND DIFFICULTY AMBULATING. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    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
    775399 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 073360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R