BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 NO-HOLE

    MDR report key: 18317938 · Received December 13, 2023

    Report

    Report Number
    3005180920-2023-01009
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810848
    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 ON 01-DEC-2023. LOT 1810302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 2024-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING LACK OF RANGE OF MOTION. AT ABOUT 4 YEARS AND 5 MONTHS AFTER PRIMARY, THE SURGEON DECIDED THAT THE PATIENT NEEDED MORE CUP INCLINATION AND RANGE OF MOTION, SO HE REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695166 CUP: MPACT ACETABULAR SHELL Ø54 NO-HOLE HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 1810302 07630030810848

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention