BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 9811229 · Received March 10, 2020

    Report

    Report Number
    3005180920-2020-00149
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 10, 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 26 FEBRUARY 2020: LOT 1904357: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-06-02. 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. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 1904649. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1904649: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEP-2018. EXPIRATION DATE: 2024-09-03. 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, 1 MONTH AFTER PRIMARY SURGERY, FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE INCISION FROM THE SURGICAL WOUND WAS LEAKING, SWOLLEN, AND RED. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272912 LINER: MPACT FLAT PE HC LINER Ø36/F ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 1904357 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention