BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ C STD 60MM HA

    MDR report key: 8347996 · Received February 18, 2019

    Report

    Report Number
    0001825034-2019-00541
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    September 19, 2018
    Report Date
    April 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 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: UNKNOWN CLAW, PN UNKNOWN, LN UNKNOWN, UNKNOWN BOLT, PN UNKNOWN, LN UNKNOWN, EPOLY RLC 36MM 10DEG SZ26, PN EP-105896, LN 724570, REGEN/RNGLC+ MULTI 66MM SZ 26, PN PT-106066, LN 258630, DELTA CERAMIC FEM HD 36/0MM, PN 650-0661, LN 3305503, ARCOS 18X150MM SPL TPR DIST HA, PN 22-300818, LN 426140. REPORT SOURCE- (B)(6). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION WITHIN THE US; HOWEVER, SIMILAR DEVICES ARE CLEARED UNDER K090757. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2019-00671, 0001825034-2019-00669. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY. APPROXIMATELY FOUR YEARS POST OP IT WAS REPORTED THAT THE PATIENT SUFFERED TROCHANTERIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140948 ARCOS CON SZ C STD 60MM HA PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 426140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other