BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 TWO-HOLE

    MDR report key: 19806143 · Received July 23, 2024

    Report

    Report Number
    3005180920-2024-00533
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812576
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 JULY 2024. LOT 2109317: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEPT-2021. EXPIRATION DATE: 2026-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 01 JULY 2024. LINER: MPACT 01.32.3239HCT FLAT PE HC LINER 32/C (K103721) LOT 2108134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2021. EXPIRATION DATE: 2026-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW 6,5 L 25 (K200391) LOT 2312899: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2023. EXPIRATION DATE: 2028-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: COCR 01.25.021 COCR BALL HEAD 12/14 32 SIZE S -3.5 (K072857) LOT 2306267: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUN-2023. EXPIRATION DATE: 2028-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND UNSTABLE HIP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP, SCREWS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906444 CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 TWO-HOLE HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 2109317 07630030812576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention