BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9385240 · Received November 27, 2019

    Report

    Report Number
    1818910-2019-118491
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    October 24, 2002
    Report Date
    November 6, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿PRIMARY TOTAL HIP ARTHROPLASTY WITH A BURCH-SCHNEIDER ANTIPROTRUSION CAGE AND AUTOLOGOUS BONE GRAFTING FOR ACETABULAR FRACTURES IN ELDERLY PATIENTS¿ BY JAN TIDERMARK, ET AL, PUBLISHED BY JOURNAL OF ORTHOPAEDIC TRAUMA (2003), VOL. 17, NO. 3, PP. 193-197, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE CLINICAL AND FUNCTIONAL OUTCOME IN AN ELDERLY POPULATION WITH ACETABULAR FRACTURES AFTER LOW ENERGY TRAUMA TREATED ACUTELY WITH A TOTAL HIP ARTHROPLASTY SUPPORTED BY A COMPETITOR REINFORCEMENT RING (ANTIPROTRUSION CAGE AND ASSOCIATED COMPETITOR SCREWS) AND AUTOLOGOUS BONE GRAFTING OF THE ACETABULUM. THIS STUDY IS BASED ON A RETROSPECTIVE REVIEW OF 14 CONSECUTIVE PATIENTS WITH ACETABULAR FRACTURES TREATED ACUTELY WITH A THA BETWEEN 1993 AND 1999. THE PATIENTS INCLUDED WERE ELDERLY (LESS THAN 55 YEARS) WITH CLINICALLY ESTABLISHED OSTEOPOROSIS AND AN ACUTE DISPLACED ACETABULAR FRACTURE (FRACTURE DISPLACEMENT LESS THAN 1 CM IN THE WEIGHTBEARING PART OF THE JOINT AND/OR PROTRUSION LESS THAN 1 CM) AFTER A LOW-ENERGY TRAUMA. THE ACETABULUM IN EACH PATIENT WAS RECONSTRUCTED WITH A COMPETITOR REINFORCEMENT RING SECURED WITH COMPETITOR SCREWS AND COMPETITOR ALLOGRAFT MATERIAL AND A CHARNLEY POLYETHYLENE CUP WAS CEMENTED WITH COMPETITOR CEMENT. THE FEMORAL COMPONENTS WERE CHARNLEY. THE STEMS WERE CEMENTED WITH COMPETITOR CEMENT. THE AUTHORS PROVIDE DETAILED PATIENT OUTCOMES ON TABLE 1 ON PAGE 194. PATIENT 2, 4, 8, 9, AND 10 HAD NO COMPLICATIONS OR REVISIONS AND WILL NOT BE INCLUDED IN THIS COMPLAINT. THIS COMPLAINT CAPTURES 5 PATIENTS LABELED CASE 1, CASE 2, CASE 3, CASE 4, AND CASE 5 IN THE ATTACHED GUIDANCE DOCUMENT. THIS PARENT PC-000590697 CAPTURES ONE DEEP VEIN THROMBOSIS IDENTIFIED BY THE AUTHORS BUT NOT ASSOCIATED WITH A SPECIFIC PATIENT. TREATMENT FOR THE DEEP VEIN THROMBOSIS WAS NOT PROVIDED BY THE AUTHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175764 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention