BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT 3D METAL ACETABULAR SHELL Ø52 TWO-HOLE

    MDR report key: 17256405 · Received July 5, 2023

    Report

    Report Number
    3005180920-2023-00493
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812590
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-JUN-2023: LOT 153942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2016. EXPIRATION DATE: 2021-01-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 13-JUN-2023: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 1810220: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2018. EXPIRATION DATE: 2023-12-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 129 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 173298: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2017. EXPIRATION DATE: 2022-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 145 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ILIOPSOAS TENDONITIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417744 MPACT 3D METAL ACETABULAR SHELL Ø52 TWO-HOLE MPACT ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.38.052DH 153942 07630030812590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention