BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK

    MDR report key: 10389669 · Received August 11, 2020

    Report

    Report Number
    3005180920-2020-00509
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802638
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 162968: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2016. EXPIRATION DATE: 2021-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 LOT. 162360 (K072857). BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 162360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45 LOT. 161084 (K091967). BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 161084: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2016. EXPIRATION DATE: 2021-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER 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 BIPOLAR HIP COMPONENTS TO TOTAL HIP COMPONENTS 3 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853924 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.23SN 162968 07630030802638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention