BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7468600 · Received April 27, 2018

    Report

    Report Number
    3005180920-2018-00287
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 2, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED ON 25 APRIL 2018 BY MEDICAL AFFAIRS (B)(4): INFECTION IN CEMENTLESS THA, 1 YEAR AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 27 APRIL 2018; LOT 174039: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2017. EXPIRATION DATE: 2022-10-08; 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. OTHERS DEVICES INVOLVED: QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 3, SHORT NECK REFERENCE 01.12.43SN (K103189); LOT 170919: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2017 EXPIRATION DATE: 2022-04-05 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. LINER NOT MARKETED IN US: LOT 173310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28; 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

    ABOUT 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR AN INFECTION. THE STEM WAS DISLODGED DURING THE PROCESS OF REMOVING THE HEAD AND LINER, THE STEM SWAP WASN'T PLANNED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310307 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 174039 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention