BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BONE CEMENT

    MDR report key: 9448779 · Received December 10, 2019

    Report

    Report Number
    1818910-2019-122196
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    August 13, 2003
    Report Date
    November 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    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 OF ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE CUP ARTICULATING WITH 22.225 MM ZIRCONIA DIAMETER HEAD IN CEMENTED TOTAL HIP ARTHROPLASTY¿ BY MICHAEL WROBLEWSKI, ET AL, PUBLISHED BY JOURNAL OF ORTHOPAEDIC SCIENCE (2004), VOL. 9, PP. 253-255, WAS REVIEWED. THE AUTHORS PRESENT THEIR EXPERIENCE WITH A 22.225MM DIAMETER ZIRCONIA HEAD ON A 9¿10 TAPER ARTICULATING WITH AN ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE (UHMWPE) CUP IN 339 CEMENTED TOTAL HIP ARTHROPLASTIES. THE THAS USED IN THIS STUDY INCLUDED AN UNKNOWN POLYETHYLENE CUP, A COMPETITOR ZIRCONIA FEMORAL HEAD, AND DEPUY CEMENT AND FEMORAL STEM. IMPLANTED DEPUY PRODUCTS: C-STEM FEMORAL STEM. ALL CUPS AND STEMS WERE CEMENTED WITH DEPUY CMW CEMENT. RESULTS: 1 TOTAL HIP REVISION DUE TO INFECTION. 4 UNKNOWN CUPS CEMENTED WITH DEPUY CMW CEMENT WERE IDENTIFIED AS LOOSE ON PROGRESSIVE RADIOLOGICAL STUDIES OVER 2 YEARS- NO REVISION OR INTERVENTION REQUIRED. 1 PERIPROSTHETIC FEMORAL FRACTURE SUSTAINED DURING AN UNSPECIFIED TRAUMA. THE FRACTURE WAS NOT ATTRIBUTED TO THE C-STEM OR THE CMW CEMENT AND IS THEREFORE NOT INCLUDED IN THIS COMPLAINT. CAPTURED IN THIS COMPLAINT: 1 C-STEM: NO REPORTED PRODUCT PROBLEM. 4 CMW CEMENT: IMPLANT LOOSENING OF AN UNKNOWN INTERFACE. PATIENT HARMS: INFECTION, MEDICAL DEVICE REMOVAL, SURGICAL INTERVENTION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243277 UNKNOWN BONE CEMENT BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1