BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 5539117 · Received March 31, 2016

    Report

    Report Number
    3005180920-2016-00123
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    February 29, 2016
    Report Date
    June 23, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 MARCH 2016. LOT 152603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2015. EXPIRATION DATE: 2020-09-29. 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. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28, CODE 01.26.2850MHC, LOT. 154206 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2015. EXPIRATION DATE: 2020-10-07. 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 Manufacturer Narrative · 1

    ON 30 MAY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH SIGNS OF AN INFECTION. THE SURGEON REVISED THE HEAD AND LINER AND WASHED OUT THE HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO X-RAYS OR EXPLANTS AVAILABLE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195829 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 152603

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention