BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 12/14 36 SIZE M 0

    MDR report key: 11176900 · Received January 15, 2021

    Report

    Report Number
    3005180920-2021-00043
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LOT 187961: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2019. EXPIRATION DATE: 2024-01-07. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LINER: MPACT 01.32.3644HC10A FACE-CHANGING 10DEG PE HC LINER 36/E (K183582)LOT. 1810850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 2024-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE MEDACTA LINER AND CUP WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. A DIRECT ANTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78132 BALL HEADS: COCR 12/14 36 SIZE M 0 BALL HEAD COCR JDI MEDACTA INTERNATIONAL SA 01.25.031 187961 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1