BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSALL/BURSTEIN II MODULAR PATELLAR COMPONENT 38 MM DIA.

    MDR report key: 6371452 · Received March 2, 2017

    Report

    Report Number
    0002648920-2017-00086
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    February 16, 2016
    Report Date
    January 24, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK892800
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. THE OPERATIVE NOTES WERE RECEIVED AND REVIEWED. DURING THE SURGERY IT WAS NOTIFIED THAT PATIENT HAD OBVIOUS INFECTION OF FEMORAL AND PATELLAR COMPONENTS AND COMPONENTS FOUND TO BE WELL ALIGNED. FURTHERMORE, IT WAS FOUND THAT FEMORAL AND PATELLAR COMPONENTS WERE LOOSED DURING THE COMPONENT REMOVING PROCESS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NEXGEN LPS-FLEX FEMORAL COMPONENT PRECOAT (00-5960-018-52, 62217448); NEXGEN FLUTED STEM TIBIAL COMPONENT (00-5996-058-01, LOT 62390852); NEXGEN LPS-FLEX ARTICULAR SURFACE (00-5962-050-12, LOT 62491561); PALACOS R RADIOPAQUE BONE CEMENT (00-1112-140-01, 76584339 X 2). THIS REPORT IS NUMBER 3 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2017-01223 AND 0001822565-2017-01209).

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED IN THE MEDICAL RECORDS THAT THE PATIENT SHOWED SIGNS OF OSTEOLYSIS UNDER THE FEMORAL AND PATELLAR COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TKA REVISION DUE TO INFECTION, IT WAS DISCOVERED THAT THE PATELLAR COMPONENT HAD BEGINNING SIGNS OF LOOSENING. THE INFECTION OCCURED GREATER THAN 1 YEAR POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155631 INSALL/BURSTEIN II MODULAR PATELLAR COMPONENT 38 MM DIA. PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62236653

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R