BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9220405 · Received October 22, 2019

    Report

    Report Number
    1818910-2019-110880
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    January 31, 2007
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> 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 ENTITLED, ¿FURLONG HYDROXYAPATITE-COATED HIP PROSTHESIS VS THE CHARNLEY CEMENTED HIP PROSTHESIS¿ BY PRAKASH CHANDRAN, MS, ET AL, PUBLISHED BY THE JOURNAL OF ARTHROPLASTY (2010), VOL. 25, NO. 1, PP. 52-57, WAS REVIEWED FOR MDR REPORTABILITY. THE AUTHORS REPORT THE RESULTS OF A PROSPECTIVE TRIAL COMPARING UNCEMENTED COMPETITOR PRODUCT HYDROXYAPATITE-COATED TOTAL HIP ARTHROPLASTY AND CEMENTED CHARNLEY (DEPUY) TOTAL HIP ARTHROPLASTY. BETWEEN 1988 AND 1993, 191 PATIENTS WERE ALLOCATED INTO 2 GROUPS DEPENDING ON THEIR YEAR OF BIRTH. ONE GROUP RECEIVED A COMPETITOR HYDROXYAPATITE-COATED TOTAL HIP ARTHROPLASTY AND THE OTHER GROUP RECEIVED A CEMENTED CHARNLEY TOTAL HIP ARTHROPLASTY (CHARNLEY MONOBLOCK ORTRON STEM WITH 22.25 MM HEAD AND THE CHARNLEY OGEE POLYETHYLENE CUP), A TOTAL OF 86 HIPS. THE CEMENT USED WAS A COMPETITOR PRODUCT. RESULTS: AT A MEAN FOLLOW-UP OF 14 YEARS (12-16 YEARS), HARRIS HIP SCORES SHOWED NO DIFFERENCE BETWEEN THE 2 GROUPS. THERE WERE NO COMPLICATIONS OR REVISIONS OF THE ACETABULAR COMPONENTS REPORTED. THERE WAS A SLOW DECLINE IN WALKING DISTANCE TOLERANCE AMONG ALL PATIENTS AT 15 YEARS FOLLOW-UP, WHICH THE AUTHORS DO NOT DIRECTLY ATTRIBUTE TO THE IMPLANTED COMPONENTS. IN PATIENTS WITH THE CHARNLEY STEM, 5 (5.2%) OF 97 HIPS HAD ASEPTIC STEM LOOSENING WITH OSTEOLYSIS REQUIRING REVISION. THERE WAS NO ASEPTIC LOOSENING OF THE CUP IN EITHER GROUP. THERE WERE NO COMPLICATIONS REPORTED WITHIN THE STUDY. 5 CHARNLEY STEMS REVISED FOR ASEPTIC LOOSENING AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016346 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention