BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11654727 · Received April 13, 2021

    Report

    Report Number
    3005180920-2021-00287
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802737
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW WAS CORRECTED ON 09-JUNE-2021. ALSO DEVICE AVAILABILITY (SECTION D9) HAS BEEN CORRECTED. BATCH REVIEW PERFORMED ON 09 JUNE 2021. LOT 141072C: 1 ITEM RE-STERILIZED AND RELEASED ON 28-AUG-2019. EXPIRATION DATE: 2024-07-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. NOTE THAT LOT 141072C IS A RE-STERILIZATION OF LOT 141072. LOT 141072: 15 ITEMS MANUFACTURED AND RELEASED ON 10-APR-2014. EXPIRATION DATE: 2025-07-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 MARCH 2021. LOT 141072C: (B)(4) ITEM MANUFACTURED AND RELEASED ON 28-AUG-2019. EXPIRATION DATE: 2024-07-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR PRIMARY HIP SURGERY ON (B)(6) 2021. DURING POST-OP RECOVERY, THE SURGEON REVIEWED POST-OP X-RAYS THAT INDICATED THE PATIENT HAD TOO MUCH OFFSET. THE SURGEON DECIDED TO REVISE THE STEM AND HEAD ON THE SAME DAY OF PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. QUADRA H SN STANDARD HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551864 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.33SN 141072C 07630030802737

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention