BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0

    MDR report key: 10319327 · Received July 24, 2020

    Report

    Report Number
    3005180920-2020-00459
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 24, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    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 13 JULY 2020: LOT 1904482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2019. EXPIRATION DATE: 2024-10-12. 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: LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 1906158. BATCH REVIEW PERFORMED ON 13 JULY 2020: LOT 1906158: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2019. EXPIRATION DATE: 2024-09-07. 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 IMPLANT INVOLVED: STEM: MASTERLOC 01.39.208 CEMENTLESS TI COATED LAT STEM SIZE 8 (K151531) LOT. 1902842. BATCH REVIEW PERFORMED ON 13 JULY 2020: LOT 1902842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2019. EXPIRATION DATE: 2024-07-15. 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 REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787851 BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0 METAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 1904482 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention