BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 10008490 · Received April 29, 2020

    Report

    Report Number
    3005180920-2020-00261
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    March 31, 2020
    Report Date
    April 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 APRIL 2020: LOT 1903450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2019. EXPIRATION DATE: 2024-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT. 1905651. BATCH REVIEW PERFORMED ON 09 APRIL 2020: LOT 1905651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2019. EXPIRATION DATE: 2024-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 1 MONTH AFTER PRIMARY SURGERY THE SURGEON REVISED THE LINER AND IMPLANTED A DM CONVERTER WITH A DUAL MOBILITY LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472783 LINER: MPACT FLAT PE HC LINER Ø36/F ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 1903450 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention