BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 21X250MM SPL TPR DIST

    MDR report key: 11320994 · Received February 12, 2021

    Report

    Report Number
    0001825034-2021-00463
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 21, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER A COMPETITOR LINER WAS IMPLANTED DURING THE REVISION IN 2013 AND THIS WOULD BE A INCOMPATIBLE DEVICE, IT IS UNKNOWN IF THIS COMPATIBILITY ISSUE WOULD OF CAUSED OR CONTRIBUTED TO THE EVENTS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 11-301345 ARCOS CON SZ E STD 175530; 650-1055 BIOLOXD OPTION HD 428120; 650-1066 TPR SLEVE 779450; 87-3435 DEPUY LINER 7930873; UNKNOWN, UNKNOWN CUP UNKNOWN; 298.801.01S DEPUY CABLE 1.7MM P314617; 298.801.01S DEPUY CABLE 1.7MM P314617; 298.801.01S DEPUY CABLE 1.7MM P314617; 298.801.01S DEPUY CABLE 1.7MM P310298; 298.801.01S DEPUY CABLE 1.7MM P313427; 1622022-1001 LIFENET CORTICAL STRUT UNKNOWN; 1619380-1000 LIFENET CORTICAL STRUT UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. 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 - 00464.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED SEVERAL TIMES. THE PATIENTS' LEGAL ATTORNEY CLAIMS THAT THE PATIENT CONTINUES TO SUFFER FROM PAIN, LOST MOBILITY AND A LEG LENGTH DISCREPANCY AS A RESULT OF THE LAST REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220176 ARCOS 21X250MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 753680

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other SEE H10