BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø32/D LOT. 1810848 SN

    MDR report key: 16467913 · Received March 2, 2023

    Report

    Report Number
    3005180920-2023-00131
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    December 2, 2022
    Report Date
    March 2, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040730778
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 FEBRUARY 2023. LOT 1810848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MARCH-2019. EXPIRATION DATE: 2024-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 27 FEBRUARY 2023: BALL HEADS: COCR 01.25.023 COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5 (K072857) LOT. 180326 LOT 180326: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2018. EXPIRATION DATE: 2023-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AFTER MEDACTA PRIMARY SURGERY PERFORMED ON (B)(6) 2022 (PREVIOUSLY THE PATIENT HAD COMPETITOR DEVICES), ON (B)(6) 2022 THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT DISLOCATION (DM LINER FROM THE DM CUP) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, HEAD, AND PROXIMAL BODY OF THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 2023-00130. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT DISLOCATION (HEAD FROM THE LINER) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, HEAD, AND SCREWS WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517970 LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø32/D LOT. 1810848 SN HIP HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3241HC10A 1810848 07630040730778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention