BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9278243 · Received November 5, 2019

    Report

    Report Number
    1818910-2019-114035
    Event Type
    Injury
    Date Received
    November 5, 2019
    Report Date
    October 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (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).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED: "COMPARISON OF A NEW MOBILE-BEARING TOTAL KNEE PROSTHESIS WITH A WXED-BEARING PROSTHESIS: A MATCHED PAIR ANALYSIS". LITERATURE ARTICLE "COMPARISON OF A NEW MOBILE-BEARING TOTAL KNEE PROSTHESIS WITH A FIXED-BEARING PROSTHESIS: A MATCHED PAIR ANALYSIS" (2008) BY FLORIAN GEIGER · HANS MAU · MARLIS KRÜGER. · MARC THOMSEN PUBLISHED BY ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY DOI 10.1007/S00402-007-0552-Z WAS REVIEWED. THE ARTICLE PURPOSE: AS NO CLINICAL STUDIES WERE AVAILABLE TO THE NEW COMPETITOR MOBILE-BEARING KNEE PROSTHESIS, THE AUTHORS DECIDED TO COMPARE IT WITH OUR ESTABLISHED CURRENT TKA IN A CONTROLLED MATCH-PAIR ANALYSIS PRIOR TO ITS GENERAL INTRODUCTION. THE ARTICLE REPORTS: TWO GROUPS WERE COMPARED; ONE GROUP WITH A COMPETITOR MOBILE-BEARING KNEE IMPLANT AND ONE GROUP WITH DEPUY PFC IMPLANTS. IN EACH GROUP THERE WERE 27 WOMEN AND THREE MEN. ALL KNEES WERE CEMENTED. PATELLAR RESURFACING WAS NOT CONDUCTED WITHIN THE PFC IMPLANT GROUP. THE AUTHORS REPORT NO STATISTICAL DIFFERENCE IN CLINICAL OUTCOMES BETWEEN THE TWO DEVICES. THERE WAS ONLY ONE COMPLICATION WITHIN THE PFC IMPLANT GROUP THAT WAS MEDIOLATERAL INSTABILITY 15 MONTHS AFTER THE INDEX OPERATION. EVENTUALLY, THIS PATIENT HAD TO UNDERGO REVISION SURGERY TO CHANGE TO A SEMICONSTRAINED COMPETITOR KNEE IMPLANT SYSTEM. COMPLICATIONS: SURGICAL INTERVENTION (1), JOINT INSTABILITY (1), MEDICAL DEVICE IMPLANT REMOVAL (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073745 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention