BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 28 SIZE XL +7

    MDR report key: 10895757 · Received November 24, 2020

    Report

    Report Number
    3005180920-2020-00828
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 24, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805134
    PMA / PMN Number
    K072857
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 6 NOVEMBER 2020: LOT 080760: 50 ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2008. EXPIRATION DATE: 2013-09-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. OTHER DEVICES INVOLVED IN THE EVENT CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL CC Ø 54 LOT. 082537 (K083116) BATCH REVIEW PERFORMED ON 6 NOVEMBER 2020: LOT 082537: 8 ITEMS MANUFACTURED AND RELEASED ON 11-DIC-2008. EXPIRATION DATE: 2013-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. LINER: VERSAFITCUP DM 01.26.2854M DOUBLE MOBILITY LINER Ø 54/28 LOT. 082980 (K083116) BATCH REVIEW PERFORMED ON 6 NOVEMBER 2020: LOT 082980: 24 ITEMS MANUFACTURED AND RELEASED ON 09-DIC-2008. EXPIRATION DATE: 2013-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 11 YEARS AND 3 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356623 BALL HEADS: COCR BALL HEAD 12/14 28 SIZE XL +7 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.014 080760 07630030805134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention