BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 22539992 · Received July 18, 2025

    Report

    Report Number
    3005180920-2025-00700
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JULY 2025 CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT. 2342592: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-02-2024. EXPIRATION DATE: 13-02-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: STEM: AMISTEM P 01.18.402 AMISTEM-P STD. SIZE2 (K173794) LOT. 2308177: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-07-2023. EXPIRATION DATE: 03-07-2028. 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. LINER: MPACT 01.32.3644HC10A FACE-CHANGING 10° PE HC LINER Ø36/E (K183582) LOT. 2004539: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-07-2020. EXPIRATION DATE: 06-07-2025. 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 01.25.034 COCR BALL HEAD 12/14 Ø36 MM SIZE XXL (K080885) LOT. 112523C: (B)(4) ITEM MANUFACTURED AND RELEASED ON 10-01-2022. EXPIRATION DATE: 14-12-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION. THE SURGEON REVISED THE FEMORAL HEAD AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INFECTION. IMAGING SHOWED AN ANTEVERTED CUP, WITH NO SIGNS OF PERIPROSTHETIC FRACTURE. NO IMPLANTS WERE REMOVED. ON (B)(6) 2025, THE PATIENT HAD A NEW DISLOCATION SUCCESSFULLY TREATED. NO IMPLANTS WERE REMOVED. DURING THE WEEK OF (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION. THE SURGEON THEN IDENTIFIED AN INFECTION, WHICH WAS THE UNIQUE REASON FOR THE REVISION. ALL IMPLANTS WERE REMOVED, AN OSTEOTOMY WAS PERFORMED, AND AN ANTIBIOTIC SPACER WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840300 MPACT ACETABULAR SYSTEM CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES LZO MEDACTA INTERNATIONAL SA 01.32.152DH 2342592 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention