BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 22727963 · Received August 6, 2025

    Report

    Report Number
    3005180920-2025-00777
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 JULY 2025: LINER: MPACT 01.32.3244HCT FLAT PE HC LINER Ø32/E (K103721) LOT 2339892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2023. EXPIRATION DATE: 2028-10-31. 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. CUP: MPACT 3D METAL 01.38.052DH MPACT 3D METAL SHELL TWO HOLE Ø52MM (K171966) LOT 2505249: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2025. EXPIRATION DATE: 2030-05-07. 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. VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: THE LINER APPEARED SLIGHTLY DAMAGED, MOST PROBABLY FOR THE SEVERAL ATTEMPTS TO INSERT IT IN THE CUP. FROM THE VISUAL ANALYSIS, EXCEPT FOR THE DAMAGE THAT OCCURRED DURING THE ATTEMPTS, NO PARTICULAR SIGNS WERE NOTICED THAT COULD BE RELATED TO IMPLANT DEFECTS; MOREOVER, A FUNCTIONAL TEST WAS DONE TO IMPACT THE LINER IN A SHELL OF THE RELATED SIZE: THE LINER WAS PROPERLY SEATED INSIDE, CONFIRMING A CORRECT DIMENSIONING AND FUNCTIONING OF THE DEVICE. FROM THE RECEIVED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT, BUT IT IS PROBABLY RELATED TO THE PRESENCE OF LIQUID OR TISSUES THAT COULD HAVE PREVENTED THE COMPLETE INSERTION OF THE LINER. ROOT CAUSE: IT IS MOST LIKELY THAT THE CAUSE OF THE REPORTED PROBLEM WAS THE PRESENCE OF SOME REMAINING LIQUID OR AN LACK OF ALIGNMENT BETWEEN THE COMPONENTS. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 JULY 2025: LINER: MPACT 01.32.3244HCT FLAT PE HC LINER Ø32/E (K103721), LOT 2339892: 100 ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2023. EXPIRATION DATE: 2028-10-31. 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 COMPONENT INVOLVED IN THE EVENT: CUP: MPACT 3D METAL 01.38.052DH MPACT 3D METAL SHELL TWO HOLE Ø52MM (K171966) LOT 2505249: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2025. EXPIRATION DATE: 2030-05-07. 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. WE ARE WAITING TO RECEIVE THE DEVICE BACK TO ANALYZE IT. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AFTER THE CUP AND SCREWS WERE INSERTED, THE LINER WAS IMPACTED AS USUAL. HOWEVER, THE LINER WAS NOT FULLY SEATED AND WAS POSITIONED 2 MM ABOVE ITS INTENDED LOCATION. THE SCREW HEADS AND ANY POSSIBLE INTERPOSING MATERIAL WERE CHECKED, AND THE LINER WAS IMPACTED AGAIN, BUT IT STILL DID NOT SEAT COMPLETELY INTO THE CUP. ONE OF THE SCREWS WAS REMOVED AND ANOTHER ATTEMPT WAS MADE TO IMPACT THE LINER, BUT IT COULD NOT BE FIXED SECURELY. DAMAGE WAS OBSERVED ON THE LINER'S TAB, SO A NEW LINER OF THE SAME TYPE BUT DIFFERENT LOT WAS OPENED AND USED. THE SECOND LINER WAS IMPACTED WITHOUT ANY ISSUES. DELAY TIME IS ABOUT 20MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765920 MPACT ACETABULAR SYSTEM FLAT PE HC LINER Ø 32 / E LZO MEDACTA INTERNATIONAL SA 01.32.3244HCT 2339892 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other