BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PRECOAT STEMMED TIBIAL COMPONENT

    MDR report key: 3452452 · Received October 30, 2013

    Report

    Report Number
    1822565-2013-01568
    Event Type
    Injury
    Date Received
    October 30, 2013
    Date of Event
    September 15, 2011
    Report Date
    February 17, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE IMPLANTED COMPONENTS WERE CHECKED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT WERE REVIEWED, INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER INC CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #64874019 - THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. SUBMITTED OCT 30, 2013. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: THE IMPLANTED COMPONENTS WERE CHECKED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT WERE REVIEWED, INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. SUBMITTED MAR 26, 2014. EVALUATION SUMMARY: REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. IT IS UNKNOWN IF THE CEMENT WAS ALLOWED TO CURE WITH THE KNEE IN FULL EXTENSION. REVIEW OF THE REVISION OPERATIVE NOTES INDICATES THAT THE TIBIAL COMPONENT WAS GROSSLY LOOSE. THE FEMORAL AND PATELLAR COMPONENTS WERE REPORTED TO BE STABLE AND WELL FIXED. RADIOGRAPHS WERE NOT PROVIDED, THEREFORE; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. UPDATE AFTER PRODUCT RETURNED AND EVALUATED: VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DEVICE EXHIBITS SIGNS OF USE AND BONE CEMENT REMAINS ON THE COMPONENT. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 KNEE PAIN.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556507 NEXGEN PRECOAT STEMMED TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 60567521

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R