BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M O

    MDR report key: 7147251 · Received December 27, 2017

    Report

    Report Number
    3005180920-2017-00778
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    November 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE 5 DECEMBER 2017 MEDACTA INTERNATIONAL INFORMED THE SUPPLIER OF THE IMPLANT, ON THE 7 DECEMBER 2017 CERAMTEC SENT TO MEDACTA THE COMPLAINT FINAL ANALYSIS REPORTING: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AND SPECIFIED AT THE TIME OF PRODUCTION. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 21 DECEMBER 2017: REVISION OF PRIMARY CEMENTLESS THR 3 WEEKS AFTER PRIMARY OPERATION DUE TO LEG LENGTH DISCREPANCY. ONLY ONE PRE-REVISION RADIOGRAPH WAS SUPPLIED, THEREFORE SUBSIDENCE OF THE STEM CANNOT BE EVALUATED. NO REASON TO SUSPECT FAULTY IMPLANTS. BATCH REVIEW PERFORMED ON 27 DECEMBER 2017: LOT 171413: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2017. EXPIRATION DATE: 2022-07-17 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.

    Description of Event or Problem · 1

    TWENTY DAYS AFTER PRIMARY SURGERY THE PATIENT COMPLAINED LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926721 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M O CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 171413 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention