BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 8184591 · Received December 20, 2018

    Report

    Report Number
    3005180920-2018-01020
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    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 19 DECEMBER 2018: LOT 182615: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2018. EXPIRATION DATE: 2023-07-15. 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: COCR BALL HEAD 12/14 Ø 36 SIZE M 0 REFERENCE 01.25.031 (K080885). LOT 182513: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUL-2018. EXPIRATION DATE: 2023-06-25. 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

    ONE HOUR AFTER THE PRIMARY, THE HEAD DISLOCATED FROM THE LINER. THE REASON FOR THE DISLOCATION IS UNKNOWN. THE SURGEON DETERMINED THE PATIENT WAS STABLE AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE HEAD AND LINER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023176 MPACT FLAT PE HC LINER Ø36/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 182615 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention