BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5

    MDR report key: 14797399 · Received June 24, 2022

    Report

    Report Number
    3005180920-2022-00488
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802171
    PMA / PMN Number
    K082792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23.JUN.2022. LOT 152232B: (B)(4). EXPIRATION DATE: 2025-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. THE OTHER DEVICE INVOLVED IN THE MIX-UP: STEM: QUADRA-S 01.12.015 CEMENTLESS, SAND BLASTED LAT STEM SIZE 5 (K072857) LOT 101086A: (B)(4). EXPIRATION DATE: 2025-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. ANALYSIS RESULTS: THE MIX-UP HAS BEEN CONFIRMED; A BOX LABELED WITH THE REF. H 01.12.035 (LOT 152232B, CEMENTLESS, HA COATED LAT STEM SIZE 5) WAS FOUND TO INCLUDE REF. 01.12.015 (LOT 101086A, QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM SIZE 5) AND VICE-VERSA. THE LETTERS "A" OR "B" ARE PRESENT AT THE END OF THE LOT NUMBERS BECAUSE THEY ARE ASSIGNED DURING THE RE-STERILIZATION PROCESSING OF THE LOTS, AS PER MEDACTA INTERNATIONAL INTERNAL PROCEDURES. BOTH LOTS INVOLVED IN THE ACTION ARE COMPOSED OF 1 DEVICE EACH. THE CORRESPONDING ITEM LABELED AS REF. 01.12.015, LOT 101086A, HAS BEEN LOCATED AND QUARANTINED. IT WAS UNDER WAREHOUSE CONTROL AND HAD NOT BEEN DISTRIBUTED TO A HOSPITAL.

    Description of Event or Problem · 0

    DURING SURGERY A QUADRA-H SIZE 5 (REF. 01.12.035, LOT 152232B) WAS OPENED AND IN THE PACKAGE THERE WAS A QUADRA-S SIZE 5 (REF. 01.12.015, LOT 101086A). A BACK-UP QUADRA-H WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957893 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5 HIP STEM CEMENTLESS JDI MEDACTA INTERNATIONAL SA 01.12.035 152232B 07630030802171

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other