BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8

    MDR report key: 11053923 · Received December 22, 2020

    Report

    Report Number
    3005180920-2020-00947
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    November 26, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802096
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17-DEC-2020: LOT 136023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2014. EXPIRATION DATE: 28-FEB-2019. 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 SINCE 2016. ADDITIONAL IMPLANT INVOLVED: LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER Ø 28 / E (K103352) LOT. 140095. BATCH REVIEW PERFORMED ON 17-DEC-2020: LOT 140095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2014. EXPIRATION DATE: 31-DEC-2018. 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 SINCE 2016.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO PERIPROSTHETIC FEMUR BONE FRACTURE, OSTEOLYSIS WAS VISIBLE. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522671 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.028 136023 07630030802096

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention