BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 20986252 · Received December 20, 2024

    Report

    Report Number
    3005180920-2024-01068
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-11-2024. LOT 170178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-06-2017. EXPIRATION DATE: 2022-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø52 (K103352) LOT 170086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-06-2017. EXPIRATION DATE: 2022-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 174034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-09-2017. EXPIRATION DATE: 2022-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENT. LOT OF THE LINER: MECTACER 01.29.413 CERAMIC LINER Ø 36 / E IS UNKNOWN. BATCH REVIEW CANNOT BE PERFORMED. PRELIMINARY INVESTIGATION BASED ON THE PICTURES RECEIVED THE EXPLANTED STEM IS COVERED WITH PATIENT BLOOD; NO HA RESIDUALS SEEM PRESENT ON THE STEM BODY, EVEN IF IT IS IMPOSSIBLE TO CONFIRM THIS EVIDENCE FROM THE IMAGES. SOME MINOR SIGNS AND SCRATCHES ARE PRESENT ON THE NECK PART PROBABLY DUE TO REVISION SURGERY. THE CUP APPEARS WITH BLOOD AND TISSUES IN THE MACROSTRUCTURES AND THE COATING APPEARED ALMOST TOTALLY ABSORBED; NO OTHER POINTS, EVIDENT SIGNS, OR DEFECTS CAN BE NOTED. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED COMPLAINT. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    PATIENT HAS HAD AN EXPLANT OF ALL PROSTHESIS FOR SUSPECTED INFECTION. INITIAL IMPLANT DATE COULD NOT BE VERIFIED. ALL IMPLANTS WERE REMOVED, STEM WAS WELL FIXED, PUS WAS NOTICIBLE FROM THE BACK OF THE CUP. A TEMPRORARY IMPLANT FROM A COMPETITOR WAS PUT IN UNTIL THE INFECTION IS TREATED. ORIGIN OF INFECTION IS NOT YET ESTABLISHED. EXPLANTED ITEMS WERE SWABBED AND THEN DISCARDED AS PER HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145671 QUADRA H FEMORAL STEMS STEM: QUADRA-H 01.12.024 CEMENTLESS, HA COATED STD STEM SIZE 4 JDI MEDACTA INTERNATIONAL SA 01.12.024 170178

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention