BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10275101 · Received July 15, 2020

    Report

    Report Number
    3005180920-2020-00438
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 15, 2020
    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 "60 JULY 2020" LOT 1901504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-12. 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 IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 06 JULY 2020. LINER: MPACT 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 1902871 LOT 1902871: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-08-12. 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 CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744821 BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE XL +7 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.014 1901504 07630030805134

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention