BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP CBL DIA2 SS CABLE SLEEVE

    MDR report key: 6114043 · Received November 18, 2016

    Report

    Report Number
    3006946279-2016-00432
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 19, 2016
    Report Date
    April 26, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDQ
    PMA / PMN Number
    PK982545
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. EVALUATION OF THE RETURNED DEVICES FOUND THE 2 CABLES WERE NOT BROKEN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO OVER-TENSIONING. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT DISTRIBUTED OR MANUFACTURED IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K982545. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 3006946279-2016-00432 / 00433). BOTH PRODUCTS WERE USED DURING THE PROCEDURE AND IT IS UNKNOWN WHICH DEVICE FRACTURED.

    Description of Event or Problem · 1

    DURING A REVISION SURGERY OF A LEFT HIP PROSTHESIS, THE CABLE FRACTURED DURING THE CABLE TENSION ADJUSTMENT. THERE WAS NO PATIENT INJURY OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762695 IMP CBL DIA2 SS CABLE SLEEVE CERCLAGE, FIXATION JDQ BIOMET FRANCE S.A.R.L. N/A 0001002749

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR