BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 58 MULTI-HOLE

    MDR report key: 12201464 · Received July 21, 2021

    Report

    Report Number
    3005180920-2021-00582
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810909
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 JUNE 2021: LOT 2000241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2020. EXPIRATION DATE: 2025-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    14 DAYS AFTER THE PRIMARY THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND ON THE LEFT SIDE IT WAS OBSERVED THAT THE CUP HAD MIGRATED AND THE CAUSE OF THE CUP MIGRATION IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS ADDING AN AUGMENT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099072 CUP: MPACT ACETABULAR SHELL 58 MULTI-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.158MH 2000241 07630030810909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention