BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14641437 · Received June 9, 2022

    Report

    Report Number
    3005180920-2022-00443
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STEM REVISED IN THE FIRST REVISION SURGERY ((B)(6) 2022) DUE TO FEMUR FRACTURE, HEAD AND LINER REPORTED BELOW WERE REVISED IN THE SECOND REVISION SURGERY ((B)(6) 2022) DUE TO INFECTION. BATCH REVIEW PERFORMED ON 27 MAY 2022. LOT 2111461: (B)(4). EXPIRATION DATE: 2027-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL COMPONENTS INVOLVED: LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø 36 / E (K103352) LOT. 2114145: (B)(4). EXPIRATION DATE: 2026-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2114367: (B)(4). EXPIRATION DATE: 2026-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: STEM DETAILS AND BATCH REVIEW. BATCH REVIEW PERFORMED ON 27 MAY 2022. LOT 2111451: (B)(4) MANUFACTURED AND RELEASED ON 25-JAN-2022. EXPIRATION DATE: 2027-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PRIMARY SURGERY WAS PERFORMED. AFTER A PERIPROSTHETIC FRACTURE, THE STEM, THE LINER, AND THE HEAD WERE REVISED ON (B)(6) 2022. PRESENTLY, (B)(6) 2022, REVISION TOOK PLACE IN (B)(6) FOLLOWING INFECTION. THE SURGEON REVISED SUCCESSFULLY THE LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055796 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 HIP STEM CEMENTLESS JDI MEDACTA INTERNATIONAL SA 01.12.23SN 2111451 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention