BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 16723121 · Received April 12, 2023

    Report

    Report Number
    3005180920-2023-00219
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 MARCH 2023: LOT 2210037: (B)(4) MANUFACTURED AND RELEASED ON 08-OCT-2022. EXPIRATION DATE: 2027-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE PATIENT HAD A MALPOSITIONED CUP AND THE CAUSE OF THE MALPOSITIONED CUP IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS 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
    1212142 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.154DH 2210037 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention