BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION BALL HEAD

    MDR report key: 5846528 · Received August 4, 2016

    Report

    Report Number
    3005180920-2016-00429
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    June 18, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON ON (B)(6) 2016 BUT, DUE TO A MISUNDERSTANDING, REPORTED IT TO MEDACTA INTERNATIONAL ONLY ON 04(B)(6) 2016. BATCH REVIEW PERFORMED ON 04 AUGUST 2016: LOT 131060: (B)(4) HEADS MANUFACTURED AND RELEASED ON 01 MARCH 2013; EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER OPTION SLEEVE SIZE M, CODE 01.29.241A LOT. 142166 (K131518): (B)(4) SLEEVES MANUFACTURED AND RELEASED ON 07 OCTOBER 2015; EXPIRATION DATE: 2020-09-19. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE ONLY THIS ITEM OF THE LOT HAVE BEEN ALREADY SOLD. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, THE SUPPLIER OF THE CERAMIC COMPONENT PROVIDED A DOCUMENT REVIEW FOR THE ITEM INVOLVED IN THIS COMPLAINT AND COMMENTED AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT.

    Description of Event or Problem · 1

    PATIENT REVISED DUE TO ANTERIOR DISLOCATION. CUP AND LINER (NOT MEDACTA) WERE REMOVED AND REPLACED (NOT WITH MEDACTA IMPLANTS) MEDACTA HEAD AND SLEEVE REMOVED AND REPLACED. XRAYS AND IMPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499333 MECTACER BIOLOX OPTION BALL HEAD CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 131060

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention