BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 8981884 · Received September 10, 2019

    Report

    Report Number
    1818910-2019-103729
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    January 1, 2012
    Report Date
    August 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED "NEW METHOD ADDRESSING HE PROBLEM OF USING CERAMIC-ON-CERAMIC BEARING IN TOO SMALL ACETABULUM OF HIGH- RIDING DDH PATIENTS WITH THA". LITERATURE ARTICLE ENTITLED, "NEW METHOD ADDRESSING THE PROBLEM OF USING CERAMIC ON CERAMIC BEARING IN TOO SMALL ACETABULUM OF HIGH-RIDING DDH PATIENTS WITH THA" BY YONGGANG ZHOU, PHD, MD, PUBLISHED IN SEMINARS ON ARTHROPLASTY (2012) VOL. 23, PP. 226-231 WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE OF THIS PAPER IS TO CONFIRM THE FEASIBILITY OF REAMING THE ACETABULUM TO 44 MM IN PATIENTS WHERE THE STANDARD 46-MM BEARING IS TOO LARGE FOR PATIENTS WITH CROWE IV DDH. BETWEEN JAN 2007 AND OCT 2010, 43 CONSECUTIVE PRIMARY THAS WERE PERFORMED IN 32 PATIENTS. ALL THE 32 PATIENTS WERE DIAGNOSED WITH CROWE TYPE IV DDH. 30 PATIENTS WERE FEMALE, AND 2 PATIENTS WERE MALE. OF THE 32 PATIENTS, 21 WERE UNILATERAL AND 11 WERE BILATERAL IN CONDITION, WHICH CONSTITUTED 43 HIPS. ALL PATIENTS RECEIVED THE THA DUE TO UNBEARABLE HIP OR SPINE PAINS. 4 PATIENTS HAD A HISTORY OF SURGERY. THE AVERAGE BODY WEIGHT WAS 54.3KG (48-69KG). THE AVERAGE AGE AT THE SURGERY WAS 31.44YR. THE DATA WERE PROSPECTIVELY COLLECTED AND RETROSPECTIVELY REVIEWED FOR ALL THE PATIENTS WITH AN AVERAGE 3.7 (RANGE, 1.5-5.2YR) YEARS OF FOLLOW-UP. NONE OF THE PATIENTS WERE DROPPED FROM FOLLOW-UP. THE AUTHORS REPLACED 41 DYSPLASTIC HIPS (IN 30 PATIENTS) WITH UNCEMENTED IMPLANTS WITH CERAMIC-ON-CERAMIC BEARINGS AND 2 HIPS (2 PATIENTS) WITH METAL-ON-POLYETHYLENE (MOP). THE ACETABULAR COMPONENTS WERE DURALOC OPTION FOR THE PATIENTS WITH COC BEARINGS AND DURALOC FOR THE PATIENTS WITH MOP BEARINGS. FOR THE 41 DYSPLASTIC HIPS (30 PATIENTS) WITH COC BEARINGS, BOTH THE ACETABULAR LINER AND HEAD COMPONENT WERE THIRD-GENERATION ALUMINA CERAMIC, BIOLOX FORTE, THE DIAMETER OF THE FEMORAL HEAD WAS 28MM AND THE CERAMIC LINER THICKNESS WAS 4.85-MM IN THESE HIPS. THE OTHER 2 PATIENTS WITH MOP BEARINGS WERE ONLY 132MM AND 130MM HIGH, RESPECTIVELY. THE AUTHORS USED A 40-MM CUP WITH MOP BEARINGS. THE APPROPRIATE SIZE OF S-ROM MODULAR STEM WAS CHOSEN IN ALL PATIENTS. A DIAPHYSEAL CRACK OCCURRED IN 3 FEMURS INTRAOPERATIVELY. THE GRAFTED BONE WAS WELL UNITED IN THE 2 PATIENTS AT THE FINAL FOLLOW-UP. ONE PATIENT HAD ACETABULAR FRACTURE, BUT THE FRACTURE UNITED AND BIOLOGICAL INGROWTH WAS SEEN AT THE FINAL FOLLOW-UP. IN ANOTHER HIP, THE BOTTOM OF ACETABULUM HAD BEEN GROUND TO LEAKAGE DURING SURGERY, BUT THE ACETABULAR PROSTHESIS HAD ENOUGH BIOLOGICAL INGROWTH AT THE FINAL FOLLOW-UP. ALL THE CUPS AND STEMS WERE STABLE. NO PATIENTS REQUIRED REVISION AT THE FINAL FOLLOW-UP. NO PATIENTS SHOWED SIGNS OF CALCAR RESORPTION, OSTEOLYSIS, COMPONENT FRACTURE, OR LOOSENING ON THE RADIOGRAPHS. NO DISLOCATION OR CERAMIC FEMORAL BALL HEAD AND LINER FRACTURES HAD OCCURRED AT THE FINAL FOLLOW-UP. NO PATIENT HAD NERVE PALSIES. NO PATIENT SENSED AND COMPLAINED OF JOINT NOISE FROM THE HIP PROSTHESIS. USING REVISION OR REQUIRING REVISION AS THE END POINT, THE SURVIVAL RATE WAS 100% AT 3.7 YRS. AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780136 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R