BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø60 NO-HOLE

    MDR report key: 12777448 · Received November 9, 2021

    Report

    Report Number
    3005180920-2021-00875
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 14, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810961
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 15 OCTOBER 2021: LOT 182581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-09-2018. EXPIRATION DATE: 2023-08-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS. IT WAS DETERMINED FROM X-RAYS THAT THE CUP HAD FRACTURED THROUGH THE ANTERIOR/MEDIAL WALL OF THE PELVIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD SUCCESSFULLY. THE PATIENT'S BONE WAS SOFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681632 MPACT ACETABULAR SHELL Ø60 NO-HOLE HIP UNCEMENTED SHELL LPH MEDACTA INTERNATIONAL SA 01.32.160SH 182581 07630030810961

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention