BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6173723 · Received December 14, 2016

    Report

    Report Number
    3005180920-2016-00650
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 11, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE STEM WAS ANALYZED, SHOWING A HA COATING TOTALLY PRESENT WITHOUT ANY PARTICULAR SIGN ON THE BODY. THE NECK SHOWED SOME LITTLE SCRATCHES OCCURRED DURING THE EXTRACTION IN THE REVISION SURGERY. FROM THE RECEIVED PIECE IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ON 09 DECEMBER 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: MEDIAL FEMORAL FRACTURE FEW DAYS AFTER PRIMARY CEMENTLESS THA. THERE IS NO REPORT OF A TRAUMATIC EVENT, IT'S POSSIBLE THAT THE FRACTURE WAS SUBSEQUENT TO A SMALL CRACK ORIGINATED DURING FEMORAL PREPARATION AT SURGERY. INTRAOPERATIVE FEMORAL FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS, DESCRIBED AND QUANTIFIED IN LITERATURE. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON 13 DECEMBER 2016. LOT 162968: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2016. EXPIRATION DATE: 2021-06-22. 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 PATIENT BEGAN HAVING PAIN IN HER RIGHT HIP 10 DAYS AFTER BILATERAL HIP SURGERY. AT X-RAY EXAMINATION A TROCHANTERIC FRACTURE WAS NOTICED. REVISION SURGERY PERFORMED DUE TO TROCHANTERIC FRACTURE APPROXIMATELY 2 WEEKS AFTER PRIMARY SURGERY (RIGHT SIDE OF PATIENT'S BILATERAL OPERATION). STEM AND HEAD WERE REMOVED. CUP AND LINER WERE LEFT IN SITU. THE REVISION SURGERY WAS COMPLETED ANTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824763 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD, SHORT NECK CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 162968

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention