BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 STD, SHORT NECK

    MDR report key: 6296391 · Received February 2, 2017

    Report

    Report Number
    3005180920-2017-00009
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    January 3, 2017
    Report Date
    March 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 03 FEBRUARY 2017 AND INCLUDES: IT WAS CONFIRMED THAT THE PRODUCTS ARE NOT AVAILABLE FOR FURTHER INVESTIGATIONS (ON THE CONTRARY OF WHAT PREVIOUSLY REPORTED IN THE INITIAL REPORT).

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 30 JANUARY 2017. LOT 151871: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 STD, SHORT NECK, CODE 01.12.24SN, LOT. 146382 (K093944) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JANUARY 2015. EXPIRATION DATE: 2019-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE SURGEON WASTED 2 STEMS AND A CERAMIC HEAD DURING A PRIMARY BILATERAL TOTAL HIP. WHEN THE SURGEON IMPLANTED THE STEM, IT SAT HIGHER THAN THE BROACH. THE STEM SAT APPROXIMATELY 8MM TO 1CM TOO HIGH ON BOTH THE LEFT AND RIGHT HIP. THE SURGEON REMOVED THE STEM, REBROACHED, AND IMPLANTED A NEW STEM ON BOTH THE LEFT AND RIGHT HIP. THIS CAUSED ABOUT A 10 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE IMPLANT WILL BE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78848 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 STD, SHORT NECK CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 151871

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other