BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC HD ARCOM XL 28X44MM

    MDR report key: 12160405 · Received July 13, 2021

    Report

    Report Number
    0001825034-2021-02073
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    September 3, 2020
    Report Date
    September 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED DEVICES IDENTIFIED THE STEM HAD GOUGING ON THE BODY AND THE TAPER OF THE DEVICE ALONG WITH BIO=DEBRIS. THE SHELL WAS RETURNED WITH BIO-DEBRIS ON THE OD AND THERE IS SCUFFING ON THE INNER RADIUS. THE BEARING WAS RETURNED ASSEMBLED WITH THE HEAD COMPONENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-104213 ¿ MALLORY HEAD STEM ¿ 061520. US157850 ¿ M2A MAGNUM CUP ¿ 929530. 650-1055 ¿ BIOLOX CERAMIC HEAD ¿ 2944830. 650-1065 ¿ CERAMIC TAPER SLEEVE ¿ 2940407. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -02071. 0001825034 -2021 -02072.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 11 YEARS POST IMPLANTATION AND A SECOND REVISION APPROXIMATELY 2 YEARS LATER DUE TO UNKNOWN REASONS. ALL PRODUCTS WERE 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
    1054966 ACT ARTIC HD ARCOM XL 28X44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 997440

    Patients

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