BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 10904614 · Received November 25, 2020

    Report

    Report Number
    0001825034-2020-04193
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 13, 2017
    Report Date
    March 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B6; D4; G3; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SUFFERED HEAVY METAL POISONING, TISSUE DEATH, BONE LOSS, AND PAIN¿LOST HER MOBILITY¿LIMITATION OF DAILY ACTIVITIES DURING THE PROCEDURE, DR. WOOD FOUND METALLOSIS IN THE SUBCUTANEOUS TISSUE AT THE HIP JOINT AND GLUTEAL FIBERS. EXCISED FIBRINOUS AND SYNOVIAL TISSUE FROM THE ACETABULAR WAS FOUND TO BE ¿NECROTIC¿ (DEAD), INFLAMMATORY REACTION, CONFIRMING HIS DIAGNOSIS OF METALLOSIS A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 139252 ITEM NAME M2A-MAGNUM 42-50MM TPR INSRT-6 LOT # 484590. ITEM# 192508 ITEM NAME ECHO POR FMRL RED LAT NC 8X120 LOT # 020100. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04192.

    Description of Event or Problem · 1

    IT WAS REPORTED INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED 5 YEARS LATER DUE TO PAIN AND METALLOSIS. DURING THE REVISION, A CERAMIC HEAD AND ACTIVE ARTICULATION SYSTEM BEARING REPLACED THE EXISTING METAL ON METAL COMPONENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368802 M2A-MAGNUM PF CUP 54ODX48ID PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 496780

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R SEE H10 NARRATIVE