BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52

    MDR report key: 7402536 · Received April 6, 2018

    Report

    Report Number
    3005180920-2018-00210
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 APRIL 2018. (B)(4). OTHER IMPLANTS INVOLVED: LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 36 / E REFERENCE 01.26.3644 (K120531). (B)(4). MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 REFERENCE 01.29.210 ( K112115) (B)(4). MOREOVER, ON 26 MARCH 2018, THE SUPPLIER OF THE BALL HEAD SEND US AN INVESTIGATION: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFILL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 23 MARCH 2018. HIP REVISION SURGERY OCCURRED 5 MONTHS AFTER PRIMARY CEMENTLESS THA DUE TO DISLOCATION. RADIOGRAPHIC IMAGES PROVIDED SHOW SUBOPTIMAL ACETABULAR SHELL POSITION. THE REASON OF THIS CHOICE CANNOT BE ASSESSED ON THE BASIS OF ONLY POSTOPERATIVE RADIOGRAPHS. IT IS NOT KNOWN IF THE CUP MIGRATED AFTER INITIAL POSITIONING OR THIS WAS THE ORIGINAL CONFIGURATION. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    ON 08 MARCH 2018 MEDACTA'S SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY WILL BE NECESSARY DUE TO IMPLANT DISLOCATION. ADDITIONAL INFORMATION RECEIVED ON 21ST MARCH 2018 BY SALES REPRESENTATIVE: THE CUP INLAY AND HEAD HAVE BEEN REMOVED. THE EXPLANTED IMPLANTS ARE NOT AVAILABLE. IT WAS NOT AN IMPLANT FAILURE BUT WRONG POSITIONING OF THE CUP ( TOO MUCH ANTEVERSION AND INCLINATION). THE REVISION WAS DUE TO BAD CUP POSITION IN PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245926 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 172505 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention