BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR CABLE SLEEVE 2.0MM

    MDR report key: 3901596 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05757
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 29, 2009
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDQ
    PMA / PMN Number
    PK982545
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿METAL SENSITIVITY, OR ALLERGIC REACTION TO A FOREIGN BODY.¿ THIS REPORT IS NUMBER 1 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05757 / 05763).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO INFECTION AND COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. THE CEMENT SPACERS WERE REMOVED ON (B)(6) 2009 AND BIOMET FEMORAL COMPONENTS AND CABLES AND COMPETITOR ACETABULAR COMPONENTS WERE IMPLANTED. A SUBSEQUENT REVISION PROCEDURE TOOK PLACE ON (B)(6) 2009 DUE TO RECURRENT INFECTION WHERE AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379248 COCR CABLE SLEEVE 2.0MM CERCLAGE, FIXATION JDQ BIOMET ORTHOPEDICS N/A 066840

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R