BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT PRECOAT SIZE -E

    MDR report key: 6431013 · Received March 24, 2017

    Report

    Report Number
    3007963827-2017-00207
    Event Type
    Injury
    Date Received
    March 24, 2017
    Report Date
    April 7, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK023211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN 2016. MEDICAL PRODUCT: NEXGEN PRECOAT STEMMED TIBIAL CATALOG #: 00-5980-047-01 LOT #: 62383320, NEXGEN CR/CR-FLEX/CRA ARTICULAR SURFACE CATALOG #: 90-5970-040-10 LOT #: 62291010, NEXGEN ALL-POLY PATELLA CATALOG #: 00-5972-065-32 LOT #: 62358016. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS (NOT EXPLANTED); HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOOSENING WAS CONFIRMED BY THE MEDICAL REPORT PROVIDED. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE 00595001506, LOT # 62077859 WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. NO COMPATIBILITY ISSUES WERE NOTED. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR LOOSENING OF THE FEMORAL COMPONENT FOR LOT #62077859. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. PRIMARY SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A RADIOLOGIC EXAMINATION PERFORMED TWO YEARS POST SURGERY CONCLUDED THAT THERE IS EVIDENCE FOR LOOSENING INVOLVING THE POSTERIOR AND MEDIAL FEMORAL COMPONENT OF THE RIGHT KNEE ARTHROPLASTY. ALSO, THE PATIENT REPORTED THAT HOSPITALIZATION TOOK PLACE THREE DAYS AFTER PRIMARY SURGERY FOR INFECTION OF RIGHT KNEE. BUT IT IS UNKNOWN IF AND HOW THIS INFECTION WAS TREATED. PER THE PACKAGE INSERTS OF THE COMPONENT, LOOSENING OF THE PROSTHETIC KNEE COMPONENTS, PAIN, AND INFECTION ARE KNOWN AS A POTENTIAL ADVERSE EFFECT OF THE TKA 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 WAS REPORTED THAT THE PATIENT IS COMPLAINING OF KNEE PAIN 3.5 YEARS AFTER TKA OF THE LEFT KNEE AND 2.5 YEARS AFTER TKA OF THE RIGHT KNEE. THE PATIENT EXPERIENCED INFECTION 3 DAYS POST-SURGERY AFTER THE RIGHT TKA, AND AN X-RAY REVEALED LOOSENING OF THE RIGHT FEMORAL COMPONENT TWO YEARS POST-SURGERY, BUT NO LOOSENING ON THE LEFT SIDE. THE PATIENT IS UNDER PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214919 FEMORAL COMPONENT PRECOAT SIZE -E KNEE PROSTHESIS JWH ZIMMER ORTHOPAEDIC MFG. LTD. 62077859

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S