BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/D

    MDR report key: 7933742 · Received October 4, 2018

    Report

    Report Number
    3005180920-2018-00746
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 OCTOBER 2018; LOT 176501: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JANUARY 2018. EXPIRATION DATE: 2022-12-26; 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 REFERENCE 01.29.205 ; LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-27; 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

    ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A SUSPECTED INFECTION. LINER HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGEON CONFIRMED THAT HE BELIEVED THIS WAS AN INFECTION OF THE WOUND AND NOT INFECTION WITHIN THE JOINT AND THIS WAS EVIDENCED BY THE DISCHARGE COMING FROM ABOVE THE MUSCLE AND ALSO AT THE LEVEL OF THE SKIN. THERE WAS NO EVIDENCE OF INFECTION OF WITHIN THE JOINT. HE IS HAPPY WITH THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776621 MPACT FLAT PE HC LINER Ø32/D FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 176501 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention