BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 7984657 · Received October 19, 2018

    Report

    Report Number
    3005180920-2018-00809
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    September 21, 2018
    Report Date
    October 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 OCTOBER 2018: LOT 133204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON OCTOBER 7, 2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT REVISED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115), LOT 150458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MAY 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 3 YEARS AFTER PRIMARY CEMENTLESS THA THE PATIENT COMPLAINS OF UNEXPLAINED PAIN. AT REVISION, THE STEM IS FOUND WELL FIXED AND LEFT IN PLACE; ONLY HEAD AND INSERT WERE CHANGED. NO OTHER INFORMATION IS AVAILABLE. WE ARE UNABLE TO DRAW ANY CONCLUSION ON THIS CASE, BUT THERE IS NO HINT THAT A FAULTY DEVICE CAN BE THE CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED THREE YEARS AFTER PRIMARY SURGERY DUE TO GENERAL PAIN: HEAD AND LINER WERE REVISED. THE CAUSE OF THE PAIN IS UNKNOWN, NO INFECTION NO FRACTURE REPORTED. CT SCAN WAS TAKEN ALONG WITH CULTURES AND NOTHING WAS WRONG THEY TRIED TO BANG THE STEM OUT BUT NOTHING HAPPENED SO THEY JUST DID A POLY/HEAD EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823736 LINER: MPACT FLAT PE HC LINER Ø36/F HIP LINER HC LPH MEDACTA INTERNATIONAL SA 133204 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention