BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/F

    MDR report key: 7634078 · Received June 25, 2018

    Report

    Report Number
    3005180920-2018-00458
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 25, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811951
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JUNE 2018: LOT 166660: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 NOVEMBER 2018. EXPIRATION DATE: 11-01-2021 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. OTHER DEVICE INVOLVED. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL +7 REFERENCE 01.29.207 (LOT 163454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 OCTOBER 2016. EXPIRATION DATE: 2021-09-21 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 COMPLAINING OF PAIN AND INSTABILITY. THE CAUSE OF PAIN AND INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFO RECEIVED BY MEDACTA USA ON THE "4TH JULY 2018": IT IS UNKNOWN IF THE INSTABILITY CAUSED THE PAIN. NO SURGEON COMMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478604 MPACT FLAT PE HC LINER Ø32/F FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 166660 07630030811951

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention