BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE XL +7

    MDR report key: 5495215 · Received March 11, 2016

    Report

    Report Number
    3005180920-2016-00089
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    October 23, 2015
    Report Date
    June 9, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10 MAY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT.ON 23 MAY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    MEDACTA WAS NOTIFIED OF THE COMPLAINT WHEN A REVISION TICKET WAS SUBMITTED FROM A DISTRIBUTOR ON (B)(6) 2016 ONLY. BATCH REVIEW PERFORMED ON 11 MARCH 2016. LOT 083841/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2014. EXPIRATION DATE: 2019-06-30. 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, CODE 01.26.2858MHC, LOT. 152105 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 HAD MULTIPLE DISLOCATIONS AFTER THE PRIMARY SURGERY. THE SURGEON DECIDED TO CHANGE THE HEAD SIZE TO A 12/14 28 MM SIZE XL +7 OFFSET AND REPLACE THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO X-RAYS OR EXPLANTS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151996 COCR BALL HEAD 12/14 Ø 28 SIZE XL +7 FEMORAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 083841/T

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention