BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/D

    MDR report key: 10331336 · Received July 28, 2020

    Report

    Report Number
    3005180920-2020-00474
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    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 15 JULY 2020: LOT 1907429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEPT-2019. EXPIRATION DATE: 2024-09-11. 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 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 1903853. BATCH REVIEW PERFORMED ON 15 JULY 2020: LOT 1903853: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2024-07-13. 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.

    Description of Event or Problem · 1

    1 DAY AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT STEM, HEAD, AND LINER FOR A DISLOCATION (HEAD FROM LINER). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798328 LINER: MPACT FLAT PE HC LINER 32/D ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 1907429 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention