BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23850112 · Received December 19, 2025

    Report

    Report Number
    3005180920-2025-01282
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810893
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 DECEMBER 2025 CUP: MPACT 01.32.158DH ACETABULAR SHELL D 58 TWO-HOLES (K132879) LOT 2349379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUNE-2024. EXPIRATION DATE: 2029-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3648HCAT HOODED PE HC LINER D 36/F (K132879) LOT 2429874: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2025. EXPIRATION DATE: 2029-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2429386: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2024. EXPIRATION DATE: 2029-10-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. STEM: QUADRA-P COLLARED 01.12.183 QUADRA-P COLLARED LAT. SIZE 3 (K192827) LOT 2316543: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2023. EXPIRATION DATE: 2028-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0020 CANCELLOUS BONE SCREW D 6,5 L20 (K200391) LOT 2413283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2024. EXPIRATION DATE: 2029-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW D 6,5 L25 (K200391) LOT. 2319122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2023. EXPIRATION DATE: 2028-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 9 MONTHS AFTER THE PRIMARY DUE TO INFECTION. ALL COMPONENTS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386468 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø58 TWO-HOLES LPH MEDACTA INTERNATIONAL SA 01.32.158DH 2349379 07630030810893

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention