BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9417695 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-120883
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    March 22, 2017
    Report Date
    November 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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, ¿WEAR RATE AND MEDIUM-TERM SURVIVAL OF A CEMENTED, MODERATELY CROSS-LINKED POLYETHYLENE ACETABULAR PROSTHESIS¿ BY BILAL M. BARKATALI, ET AL, PUBLISHED BY HIP INTERNATIONAL (2017), 6 PAGES, DOI 10.5301/HIPINT.5000521, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT THE MEDIUM-TERM RESULTS AND WEAR RATE OF THE DEPUY MARATHON CEMENTED POLYETHYLENE CUP IMPLANTED IN 103 THAS BETWEEN 2008 AND 2009. IMPLANTED DEPUY PRODUCTS: CEMENTED MARATHON POLYETHYLENE CUPS, UNKNOWN FEMORAL HEADS, AND A VARIETY OF DEPUY STEMS: CEMENTED C-STEM, CEMENTLESS CORAIL, AND CEMENTLESS KAR. THE CEMENT USED WAS A COMPETITOR PRODUCT. RESULTS: 5 POST-OPERATIVE DEEP VEIN THROMBI- NO TREATMENT SPECIFIED. 2 DISLOCATIONS- NO TREATMENT SPECIFIED. 9 SUPERFICIAL INFECTIONS- NO TREATMENT SPECIFIED. CAPTURED IN THIS COMPLAINT: MARATHON CUP: IMPLANT DISLOCATION. FEMORAL HEAD: IMPLANT DISLOCATION. FEMORAL STEM: NO REPORTED PRODUCT PROBLEM. PATIENT HARMS: INFECTION, JOINT DISLOCATION, DVT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211305 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention