BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-S 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3

    MDR report key: 12364714 · Received August 25, 2021

    Report

    Report Number
    3005180920-2021-00673
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 JULY 2021: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2009. EXPIRATION DATE: 2014-JUNE-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 29 JULY 2021: VERSAFITCUP DM 01.26.2852M DOUBLE MOBILITY LINER DIAM 52/28 (K083116) LOT. 092006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2009. EXPIRATION DATE: 2014-JULY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE X-RAYS REVEALED THAT THERE OSTEOLYSIS AROUND THE FEMUR. THE CAUSE OF THE OSTEOLYSIS IS UNKNOWN. 11 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PUT BONE GRAFT AROUND THE FEMUR AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264564 QUADRA-S 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3 FEMORAL COMPONENT JDI MEDACTA INTERNATIONAL SA 01.12.023 091592 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention