BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT CHROME CABLE/SLEEVE SET 2.0MM DIA. X 750MM LGTH.

    MDR report key: 2221824 · Received August 24, 2011

    Report

    Report Number
    1825034-2011-00749
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2009
    Report Date
    August 1, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDQ
    PMA / PMN Number
    K982545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "BENDING OR FRACTURE OF THE IMPLANT." "REMOVE AFTER FRACTURE HAS HEALED.....THE SURGEON SHOULD WEIGH THE RISKS VERSES BENEFITS WHEN DECIDING WHETHER TO REMOVE THE IMPLANT." DATE OF EVENT - THE REPORTED INFORMATION INDICATES THE ISSUE OCCURRED ON OR ABOUT (B)(4), 2009. DATE EXPLANTED - IT IS NOT CLEAR FROM THE REPORT WHETHER A REVISION PROCEDURE TOOK PLACE; THE REPORT INDICATES THAT A PORTION OF THE CABLE WAS REMOVED. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY PROCEDURE UTILIZING A CABLE SLEEVE SET ON (B)(6), 2000. THE PATIENT SUBSEQUENTLY ALLEGED TO HAVE FELT SOMETHING SHARP PROTRUDING THROUGH HIS BUTTOCKS ON OR ABOUT (B)(6), 2009 AND THAT A PORTION OF THE CABLE WAS REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT CHROME CABLE/SLEEVE SET 2.0MM DIA. X 750MM LGTH. CERCLAGE, FIXATION JDQ BIOMET ORTHOPEDICS N/A 324210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R