BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5

    MDR report key: 17387413 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00548
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805226
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 JULY 2023. LOT 121068: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2012. EXPIRATION DATE: 2017-FEB-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT (CONSIDERING ALSO RESTERILIZED PIECES) HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDTIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 4 JULY 2023 ON STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2 (K093944) LOT. 155651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2016. EXPIRATION DATE: 2021-JAN-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT (CONSIDERING ALSO RESTERILIZED PIECES) HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION DUE TO INFLAMMATION FOR SUSPECTED TRUNNIONOSIS, ABOUT 6 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY. CUP, LINER, AND HEAD REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632508 BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 HIP COCR BALL HEADS JDI MEDACTA INTERNATIONAL SA 121068 07630030805226

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention