BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12466363 · Received September 14, 2021

    Report

    Report Number
    3005180920-2021-00735
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805134
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 AUGUST 2021: LOT 130914: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUNE-2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT ON THIS LOT SINCE 2017. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER 28/DMG (K092265) LOT. 152102. BATCH REVIEW PERFORMED ON 23 AUGUST 2021: LOT 152102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3 (K093944) LOT. 154485. BATCH REVIEW PERFORMED ON 23 AUGUST 2021. LOT 154485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2015. EXPIRATION DATE: 2020-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT ON THIS LOT SINCE 2017.

    Description of Event or Problem · 1

    5 YEARS AND 7 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363239 BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE XL +7 METAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.014 130914 07630030805134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention