BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 17349847 · Received July 19, 2023

    Report

    Report Number
    3005180920-2023-00526
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 JUNE 2023: LOT 2302200: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MARCH-2023. EXPIRATION DATE: 2028-03-08. 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. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 26 JUNE 2023. BALL HEADS: COCR 01.25.030 COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 (K080885) LOT. 2244748 LOT 2244748: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2022. EXPIRATION DATE: 2028-01-18. 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

    DURING POST-OP RECOVERY, THE SAME DAY OF THE PRIMARY SURGERY, REVISION SURGERY PERFORMED DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE LINER (WITH A FACE CHANGE 10° LINER) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124486 LINER: MPACT FLAT PE HC LINER Ø36/E HIP LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2302200 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention