BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5

    MDR report key: 11138889 · Received January 8, 2021

    Report

    Report Number
    3005180920-2021-00022
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 11, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805158
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LOT 2001940: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2020. EXPIRATION DATE: 2025-06-18. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: ONE MONTH AFTER PRIMARY CEMENTLESS THA DISLOCATION OCCURS AND THE HEAD IS EXCHANGED TO A LONGER ONE. NO DEVICE MALFUNCTION, THE ROOT CAUSE IS MOST PROBABLY INSUFFICIENT SOFT TISSUE TENSION AND RELAXATION SECONDARY TO SURGERY AND REHABILITATION. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LINER: CC E CC LIGHT 01.26.3239HCT FLAT PE HC LINER Ø 32 / C (K120531)LOT. 2006350. LOT 2006350: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2020. EXPIRATION DATE: 2025-07-14. 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

    DISLOCATION HEAD FROM LINER (NO LOOSENING) AFTER 2 MONTHS FROM THE PRIMARY SURGERY. FEMORAL HEAD HAS BEEN SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39764 BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5 BALL HEADS: COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.021 2001940 07630030805158

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention