BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø 36/G

    MDR report key: 5765059 · Received July 1, 2016

    Report

    Report Number
    3005180920-2016-00323
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 3, 2016
    Report Date
    July 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 28 JUNE 2016. LOT 122760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 NOVEMBER 2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S, CODE 01.29.208, LOT. 151161 ((B)(4)); (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 APRIL 2015. EXPIRATION DATE: 2020-03-31 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.

    Additional Manufacturer Narrative · 1

    ON 11 JULY 2016 (B)(4) PROVIDED A DOCUMENT OF THE CERAMIC USED TO PRODUCE THE BALL HEAD INVOLVED IN THE COMPLAINT, REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF THE PRODUCTION. THERE ARE NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON REVISED THE HEAD AND LINER FROM A 36MM TO A 40MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420174 MPACT FLAT PE HC LINER Ø 36/G FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 122760

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention