BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 8711274 · Received June 19, 2019

    Report

    Report Number
    3005180920-2019-00486
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JUNE 2019: LOT 185986: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 SEPTEMBER 2018. EXPIRATION DATE: 2023-09-06. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. ANOTHER DEVICE WAS INVOLVED IN THE COMPLAINT. BATCH REVIEW PERFORMED ON 17 JUNE 2019: BALL HEADS: COCR 01.25.033 COCR BALL HEAD 12/14 Ø 36 SIZE XL +7, LOT. 173617 (K080885): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 NOVEMBER 2017. EXPIRATION DATE: 2022-10-29. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 5 MONTHS AFTER PRIMARY REVISION SURGERY FOR HIP DISLOCATION (HEAD FROM LINER). THE SURGERY WAS COMPLETED SUCCESSFULLY SWAPPING THE CUP, THE LINER AND THE HEAD. POSTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507357 LINER: MPACT FLAT PE HC LINER Ø36/E HIP FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 185986 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention