BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT

    MDR report key: 5623886 · Received May 2, 2016

    Report

    Report Number
    0001822565-2016-01234
    Event Type
    Injury
    Date Received
    May 2, 2016
    Date of Event
    April 4, 2016
    Report Date
    April 13, 2017
    Manufacturer
    ZIMMER, INC. - BUILDING 5
    Product Code
    JWH
    PMA / PMN Number
    PK991581
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENEDED WHEN OUR INVESTIGATION IS COMPLETE. H3 OTHER TEXT : RETURNED, NOT YET EVALUATED

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT - ZIMMER NEXGEN LPS-FLEX FEMORAL COMPONENT, SIZE F, LEFT CATALOG# 00-5960-016-51, LOT# 61429049, ZIMMER NEXGEN FLUTED STEMMED TIBIAL COMPONENT, PRECOAT, SIZE 2 CATALOG# 00-5946-060-01, LOT# 61115315, ZIMMER NEXGEN ALL PLOY PATELLA, SIZE 32, 8.5 MM THICKNESS CATALOG# 00-5972-065-32, LOT# 61407342. THERAPY DATE: (B)(6) 2016. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION THE ARTICULAR SURFACE EXHIBITS HEAVY GOUGING ON THE PROXIMAL SURFACE. THE DEVICE ALSO EXHIBITS A YELLOW DISCOLORATION THAT MAY BE ASSOCIATED WITH OXIDATION FROM IMPLANTATION. THERE ALSO EXIST ARTICULAR SURFACE POST FRAGMENT SHEARED OFF. REVIEW OF THE COMPATIBILITY MATRIX IDENTIFIED THAT ALL THE COMPONENTS ARE COMPATIBLE (FEMORAL WITH ARTICULAR SURFACE AND PATELLA; TIBIA WITH ARTICULAR SURFACE).DHR 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 WERE TRENDS IDENTIFIED. PER THE PACKAGING INSERT FOR THE ARTICULAR SURFACE, IMPLANT FRACTURE AND METAL SENSITIVITY ARE CONSIDERED TO BE KNOWN ADVERSE EFFECTS OF THE PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, KNEE-LOCKING AND POST-OPERATIVE BREAKAGE OF THE ARTICULAR SURFACE POST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE REVISION SURGERY AS THE PATIENT WAS COMPLAINING OF PAIN AND KNEE LOCKING. DURING REVISION SURGERY, SURGEON NOTICED TIBIA POST HAD SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279039 NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT JWH JWH ZIMMER, INC. - BUILDING 5 61466678

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention