BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD

    MDR report key: 10069873 · Received May 19, 2020

    Report

    Report Number
    0001825034-2020-02041
    Event Type
    Injury
    Date Received
    May 19, 2020
    Date of Event
    January 17, 2019
    Report Date
    July 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: G4; H2; H3; H6. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING, EBL 250 ML, CLOUDY JOINT FLUID WITH STAINING OF THE SYNOVIUM, POCKET OF FLUID IN SUPERIOR AND ANTERIOR ASPECT OF THE ACETABULUM, BUT OTHERWISE NO BONY DESTRUCTION AND IMPLANTS WERE WELL FIXED AND STABLE. POST OP DIAGNOSIS FAILED RIGHT THA WITH METALLOSIS AND PAIN. PSEUDOCAPSULE REMOVED, SUPERIOR AND ANTERIOR CYST WAS FOUND AND DEBRIDED, ADD FIINAL COMPONENTS WERE PLACED. PATIENT WAS TAKEN THROUGH RANGE OF MOTION WITH GOOD RESULTS. (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND ROOT CAUSE WAS UNABLE TO 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL DEVICES: ITEM # US157856/ M2A-MAGNUM PF CUP / LOT # 899260; ITEM # 139252/ M2A-MAGNUM TPR INSRT/LOT # 020580; ITEM# 15-103205/ TAPERLOC MICRO LAT/ LOT# 255540. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -02040, 0001825034 -2020 -02042.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO PAIN AND METALLOSIS. PSEUDOCAPSULE WAS REMOVED. SUPERIOR AND ANTERIOR CYST WERE FOUND AND DEBRIDED. HEAD COMPONENT WAS REMOVED AND REPLACED. 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
    532108 M2A-MAGNUM MODULAR HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 632540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.