BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/E

    MDR report key: 11892521 · Received May 27, 2021

    Report

    Report Number
    3005180920-2021-00425
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 27, 2021
    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 07.MAY.2021: LOT 188901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 3DMETAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE (K171966) LOT. 153941: BATCH REVIEW PERFORMED ON 07.MAY.2021: LOT 153941: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-APR-2016. EXPIRATION DATE: 2021-01-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: PRELIMINARY INVESTIGATION PERFORMED ON 26TH MAY 2021. THE IMAGES SHOW THE IMPLANT JUST EXPLANTED, COVERED WITH TISSUES AND BLOOD AND WITH NO VISIBLE PARTICULAR SIGNS. FROM THE RECEIVED INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. A FURTHER DEEPER ANALYSIS COULD BE PERFORMED AFTER THE RECEIPT OF THE PIECES.

    Description of Event or Problem · 1

    2 YEARS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DO TO DEVELOPING ILIOPSOAS TENDONITIS. THE CAUSE OF THE ILIOPSOAS TENDONITIS IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790926 LINER: MPACT FLAT PE HC LINER 36/E ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 188901 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention