BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM -6

    MDR report key: 12446558 · Received September 9, 2021

    Report

    Report Number
    0001825034-2021-02633
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    December 3, 2020
    Report Date
    August 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. A SELEX/MAGNUM MOD HD 40MM -6, PART # S061140 FROM LOT 570640, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND DARK GREENISH DEBRIS WITHIN THE TAPER OF THE HEAD. THE HEADS OUTER RADIUS IS SCUFFED AND SCRATCHED IN MULTIPLE LOCATIONS. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS, IDENTIFIED THE PATIENT WAS REVISED, DUE TO PAIN AND ELEVATED METAL IONS. PAINFUL MOM THA WITH ELEVATED COBALT AND CHROMIUM LEVELS. DISRUPTION AND SCARRING OF THE ABDUCTORS NOTED. PSEUDOCAPSULE, NECROTIC MATERIAL AND METALLOSIS DEBRIDED. WEAR NOTED, AT THE TRUNNION, BUT UNSURE IF CORRODED. HEAD WAS REVISED WITH CERAMIC HEAD AND POLY LINER. THE DEVICE HISTORY RECORD (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 REPORT 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US257846 644220 MAGNUM TRISPIKE CUP 46ODX40ID 0MM 11-103204 930670 TAPERLOC POR FMRL LAT 10X140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02631, 0001825034-2021-02634.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED METAL IONS. DURING THE REVISION, PSEUDOCAPSULE, NECROSIS, SCAR TISSUE, AND METALLOSIS WERE DEBRIDED. IMPLANT WEAR WAS NOTED AT THE TRUNNION. THE INITIAL HEAD WAS REPLACED WITH A DUAL MOBILITY CONSTRUCT WITHOUT COMPLICATION. 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
    1345083 SELEX/MAGNUM MOD HD 40MM -6 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 570640

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R