BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23166788 · Received September 29, 2025

    Report

    Report Number
    3005180920-2025-00920
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2025: LINER: MPACT 01.32.3252HCAT HOODED PE HC LINER Ø32/G (K132879) LOT 181530: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2018. EXPIRATION DATE: 2023-05-23. 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 DEVICES ALSO INVOLVED: MPACT 01.32.160MH ACETABULAR SHELL Ø60 MULTI-HOLE (K132879) LOT 145867B: (B)(4) ITEM MANUFACTURED AND RELEASED ON 16-JUNE-2020. EXPIRATION DATE: 2020-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø32 MM SIZE M (K072857) LOT 177203: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2018. EXPIRATION DATE: 2023-30-01. 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

    THE PATIENT HAD A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON BELIEVED THE DISLOCATION WAS DUE TO THE CUP BEING RETROVERTED AND UNDERREAMED FROM THE PRIMARY SURGERY. AT ABOUT 4 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409848 MPACT ACETABULAR SYSTEM HOODED PE HC LINER Ø32/G LPH MEDACTA INTERNATIONAL SA 01.32.3252HCAT 181530

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention