BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

    MDR report key: 5353856 · Received January 8, 2016

    Report

    Report Number
    3005180920-2015-00368
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 11, 2015
    Report Date
    April 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT THE PRIMARY SURGERY ON (B)(6) 2014, BUT SHE HAD THE CUP, HEAD AND LINER REVISED ON (B)(6) 2015 (MDR 2015-00034). ON (B)(6) 2015, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: REVISION OF THE BALL HEAD LESS THAN ONE YEAR AFTER PRIMARY. THE PURPOSE OF REVISION WAS TO LENGTHEN THE LIMB, AND AN IRRIGATION WAS PERFORMED, BUT NO INFECTION DETECTED. PATIENT WAS COMPLAINING OF HIP PAIN. THERE IS NO DOCUMENTATION THAT ALLOWS EVALUATION OF BIOMECHANICS AND HIP GEOMETRY BEFORE AND AFTER REVISION. NO REASON TO SUSPECT THAT THE ROOT CAUSE IS RELATED TO IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON (B)(6) 2016: LOT 120548: (B)(6) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: (B)(6) 2017. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ON 09MAR2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 14MAR2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF ANTERIOR HIP PAIN. AN IRRIGATION AND DEBRIDEMENT ALONG WITH INCREASING THE BALL HEAD SIZE FROM A 32MM SIZE S TO A 32MM SIZE M. THERE WAS NO INFECTION DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12452 COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5 HIP PROSTHESIS BALL HEAD JDI MEDACTA INTERNATIONAL SA 120548

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention