BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 6173744 · Received December 14, 2016

    Report

    Report Number
    3005180920-2016-00653
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 14, 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 13 DECEMBER 2016. LOT 115132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2012. EXPIRATION DATE: 2017-04-30. 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. MPACT FLAT PE HC LINER Ø36/F, CODE 01.32.3648HCT, LOT. 130418 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MARCH 2013. EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 M 0, CODE 01.29.209, LOT. 130324 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF A DIFFERENCE IN LIMB LENGTH. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824063 MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 115132

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention