BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR CABLE SLEEVE

    MDR report key: 8062512 · Received November 12, 2018

    Report

    Report Number
    0001825034-2018-10550
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K982545
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-301312 ARCOS CON 491000; 11-300922 ARCOS DISTAL TAPER 501080; (B)(6) RENG RINGLOC SHELL 150750; 11-107323 FREEDOM STANDARD LINER 363880; 11-107018 FREEDOM CONSTRAINED HEAD 968260; 120002 COCR TROCH CABLE 516680 ; 120005 COCR CABLE SLEEVE 609390 (QTY 4); 103531 PROFILE SCREW 930580 (QTY 5). 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILE ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10545; 0001825034-2018-10547;0001825034-2018-10548;0001825034-2018-10549;0001825034-2018-10550; 0001825034-2018-10553; 0001825034-2018-10555.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED RIGHT HIP DRAINAGE WITH DIVERTICULITIS AND UTI AT AN UNKNOWN AMOUNT OF TIME POST RIGHT HIP REVISION. 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
    899182 COCR CABLE SLEEVE PROSTHESIS, TRAUMA HRS ZIMMER BIOMET, INC. N/A 609390

    Patients

    Seq Age Sex Outcome Treatment
    1