BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7897542 · Received September 21, 2018

    Report

    Report Number
    3005180920-2018-00716
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802638
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2018: LOT 177576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MARCH 2018. EXPIRATION DATE: 2023-03-04. 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. ADDITIONAL PRODUCT IMPLANTED IN PRIMARY, NOT EXPLANTED DURING THE ADDITIONAL SURGERY: CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879), LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 OCTOBER 2017. EXPIRATION DATE: 2022-09-24. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON SEP 4, 2018: 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.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE AGENT WAS IN THEATRE WITH THE SURGEON WHO INFORMED HIM THAT THE PATIENT WAS FOUND TO HAVE A GT FRACTURE IMMEDIATELY AFTER PRIMARY CASE. THE INTRA-OP X-RAY TAKEN DURING PRIMARY DIDN'T SHOW ANY EVIDENCE OF FRACTURE WITH TRIAL IMPLANTS IN PLACE. HOWEVER THE POST OP XRAY IN RECOVERY SHOWED A POSSIBLE GT FRACTURE. THE PATIENT WAS SENT OFF FOR CT SCAN AND IT WAS CONFIRMED THERE WAS FEMUR, GT AND PELVIC FRACTURE. A MEDACTA REP ATTENDED THE PRIMARY CASE AND SAID THERE WAS NOTHING UNTOWARD DURING THE PROCEDURE, PATIENT WAS NOT OVERWEIGHT AND THERE WAS NO MENTION OF FRACTURE DURING THE PROCEDURE OR UNDERLYING EXTENSIVE DISEASE BONE DISEASE. THE SURGEON STATED THAT THE PATIENT HAD AVN. THE PATIENT WAS REOPERATED ON (B)(6) 2018: NO MEDACTA IMPLANT WAS REVISED, BUT ONLY CABLES WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738624 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.23SN 177576 07630030802638

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention