BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23434514 · Received October 31, 2025

    Report

    Report Number
    3005180920-2025-01050
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    December 23, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030810855
    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 15 OCTOBER 2025 SCREWS: IMPACT 01.43.0040 CANCELLOUS BONE SCREW Ø 6,5 L40 (K200391) LOT 2109268: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 21-OCT-2026. 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: IMPACT 01.43.0020 CANCELLOUS BONE SCREW Ø 6,5 L20 (K200391) LOT 2218850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2022. EXPIRATION DATE: 28-SEP-2027. 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: IMPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT 2420493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2024. EXPIRATION DATE: 28-OCT-2029. 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. ROOT CAUSE: 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.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 OCTOBER 2025. SCREWS: MPACT 01.43.0040 CANCELLOUS BONE SCREW Ø 6,5 L40 (K200391) LOT 2109268: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 21-OCT-2026. 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 01.43.0020 CANCELLOUS BONE SCREW Ø 6,5 L20 (K200391) LOT 2218850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2022. EXPIRATION DATE: 28-SEP-2027. 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 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT 2420493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2024. EXPIRATION DATE: 28-OCT-2029. 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. CLINICAL EVALUATION BY OUR CLINICAL AFFAIRS DIRECTOR. THREE MONTHS AFTER PRIMARY CEMENTLESS THA, THE ACETABULAR CUP DEMONSTRATED SIGNIFICANT MOBILIZATION DESPITE FIXATION WITH TWO BONE SCREWS. NO TRAUMATIC EVENT WAS REPORTED, ALTHOUGH SUCH A DEGREE OF MOBILIZATION WOULD TYPICALLY BE ASSOCIATED WITH TRAUMA. THE CUP FAILED TO ACHIEVE SECONDARY FIXATION THROUGH BONE ONGROWTH AND THEREFORE REQUIRED REVISION. THERE IS NO EVIDENCE TO SUGGEST A DEVICE-RELATED FAILURE. THE EVENT WAS MOST LIKELY CAUSED BY EITHER AN UNREPORTED MINOR TRAUMATIC EVENT OR INSUFFICIENT BONE ONGROWTH AT THE IMPLANT-BONE INTERFACE. CONCLUSION: ALTHOUGH A PRECISE ROOT CAUSE CANNOT BE ESTABLISHED, THE CUP FAILED TO ACHIEVE SECONDARY FIXATION, LIKELY DUE TO INSUFFICIENT BONE ONGROWTH AT THE IMPLANT-BONE INTERFACE OR AS A CONSEQUENCE OF A MINOR TRAUMATIC EVENT NOT REPORTED IN THE COMPLAINT. THERE IS NO INDICATION THAT ANY DEVICE-RELATED ISSUE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY POTENTIAL MANUFACTURING-RELATED ISSUES.

    Description of Event or Problem · 0

    ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEON REVISED THE CUP, SCREWS (ONE WAS FOUND BROKEN), HEAD, AND LINER TO A COMPETITOR'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562936 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø56 TWO-HOLES LZO MEDACTA INTERNATIONAL SA 01.32.156DH 2420493 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention