BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

    MDR report key: 6731941 · Received July 21, 2017

    Report

    Report Number
    3005180920-2017-00400
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 22, 2017
    Report Date
    July 21, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860997
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THIS PATIENT. THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT HAD A POLY AND HEAD REVISED DUE TO INFECTION. THEN, THE PATIENT WAS REVISED AGAIN FOR INFECTION ON (B)(6) 2017. BATCH REVIEWS PERFORMED ON 21 JULY 2017. LOT 165665: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2016. EXPIRATION DATE: 2021-12-08. 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. COCR BALL HEAD 12/14 Ø 28 SIZE M 0, CODE 01.25.012, LOT. 163206 (K072857) LOT 163206: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2016. EXPIRATION DATE: 2021-07-17. 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. MPACT DM DOUBLE MOBILITY HC LINER 28/DMH, CODE 01.26.2856MHC, LOT. 164475 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2016. EXPIRATION DATE: 2021-09-20. 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. AMISTEM C, CEMENTED STEM SIZE 3 STD, CODE 01.18.153, LOT. 165834 (K103189) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 DECEMBER 2016. EXPIRATION DATE: 2021-12-01. 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

    THE PATIENT WAS REVISED FOR INFECTION. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511325 MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 165665 07630030860997

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention