BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM SIZE 3

    MDR report key: 18020076 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00829
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802157
    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 04-OCT-2023. LOT 2010667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 04-OCT-2023: CUP: VERSAFITCUP CC TRIO 01.26.45.0054 ACETABULAR SHELL CC TRIO Ø 54 (K103352) LOT 2200445: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2204282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2022. EXPIRATION DATE: 2027-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: MECTACER 01.29.413 CERAMIC LINER Ø 36 / E (DEVICE NOT DISTRIBUTED IN US) LOT 2117207: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2022. EXPIRATION DATE: 2027-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF A CITROBACTER KOSERI INFECTION AND STEM LOOSENING. ALL IMPLANTS WERE REMOVED AND A G SPACER HAS BEEN PUT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712896 STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM SIZE 3 HIP CEMENTLESS, HA COATED LAT STEM JDI MEDACTA INTERNATIONAL SA 2010667 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention