BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9416619 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-120728
    Event Type
    Injury
    Date Received
    December 5, 2019
    Report Date
    November 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    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. INVESTIGATION SUMMARY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿EXETER-OGEE TOTAL HIP REPLACEMENT USING THE HARDINGE APPROACH; THE TEN TO TWELVE YEAR RESULTS¿ BY G. J. C. MYERS, ET AL, PUBLISHED BY HIP INTERNATIONAL (2008), VOL. 18, NO. 1, PP. 35-39, WAS REVIEWED. THE AIM OF THIS ARTICLE WAS TO ESTABLISH WHETHER THE PUBLISHED RESULTS FOR A COMPETITOR STEM AND FEMORAL HEAD USING THE OGEE ELITE ACETABULAR COMPONENT AND A HARDINGE APPROACH. IMPLANTED DEPUY PRODUCTS: CHARNLEY OGEE ELITE CUP SECURED WITH UNKNOWN CEMENT. THE FEMORAL COMPONENTS USED WERE COMPETITOR PRODUCTS. RESULTS: 5 REVISIONS DUE TO INFECTION. ONE OF THESE REVISIONS REVEALED AN INTRAOPERATIVE ACETABULAR FRACTURE SECONDARY TO PREEXISTING AVASCULAR NECROSIS AND OSTEOARTHRITIS. THE FRACTURE WAS NOT ATTRIBUTED TO THE CUP AND WILL THEREFORE NOT BE INCLUDED IN THIS COMPLAINT. 1 CUP WAS REVISED FOR ASEPTIC LOOSENING. THERE IS INSUFFICIENT INFORMATION TO ATTRIBUTE THE ASEPTIC LOOSENING TO THE OGEE CUP SECURED WITH COMPETITOR CEMENT. CAPTURED IN THIS COMPLAINT: 5 OGEE ELITE PLUS CUPS: NO REPORTED PRODUCT PROBLEM. PATIENT HARMS: INFECTION, SURGICAL INTERVENTION, AND MEDICAL DEVICE REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210255 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention