BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK

    MDR report key: 5267515 · Received December 4, 2015

    Report

    Report Number
    3005180920-2015-00307
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    November 6, 2015
    Report Date
    January 14, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2015 THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER. THE CASE WAS FINALLY CLOSED ON 26 DEC 2015.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 THE R&D PROJECT MANAGER MADE THE FOLLOWING ANALYSIS ON THE RETRIEVED ITEMS: IT WAS NOT POSSIBLE TO UNSCREW BY HAND THE INSTRUMENT FROM THE CUP, SO THE INSTRUMENT WAS DISASSEMBLED WITH A KEY BÖCKING THE CUP WITH A TOOL. THE CONTACT SURFACES BETWEEN TERMINAL AND CUP DO NOT PRESENT SIGNS OF EXCESSIVE WEAR. THE ISSUE IS LIKELY DUE TO TOO MUCH STRENGTH USED DURING THE SCREWING OF THE TERMINAL IN THE CUP. BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 1411056: (B)(4) INSTRUMENTS MANUFACTURED AND RELEASED ON (B)(6) 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. FOURTH CASE ON THE SAME LOT. CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM 54, CODE (B)(4), LOT. 150063 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON (B)(6) 2015 A FINAL REPORT WAS PREPARED WITH THE INFORMATION HERE ABOVE.

    Description of Event or Problem · 1

    THE TERMINAL CUP IMPACTOR GOT STUCK INTO THE CUP. ANOTHER CUP AND ANOTHER IMPACTOR HAVE BEEN USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799013 TERMINAL CUP IMPACTOR FOR METAL BACK SURGICAL INSTRUMENT FOR HIP REPLACEMENT LXH MEDACTA INTERNATIONAL SA 1411056

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention