BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNGD CR TIB BRG 10X71/75

    MDR report key: 6996621 · Received November 2, 2017

    Report

    Report Number
    0001825034-2014-08839
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 23, 2014
    Report Date
    November 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT: (B)(4). PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR EVALUATION. THE TRAY WAS INSPECTED AND A CRACK NEAR THE INSIDE OF THE SEALING FLANGE WAS CONFIRMED. THIS CRACK WAS CAUSED BY AN EXTREME DISTRIBUTION EVENT AS NO FAILURES OF THE OUTER TRAY/LID WERE SEEN DURING THE PACKAGING PERFORMANCE VALIDATION. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES FOR THIS LOT. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Additional Manufacturer Narrative · 1

    RESULTS OF THE PER RELAYED BY THE ENGINEER: THE TRAY WAS INSPECTED AND A CRACK NEAR THE INSIDE OF THE SEALING FLANGE WAS CONFIRMED. THIS CRACK WAS CAUSED BY AN EXTREME DISTRIBUTION EVENT AS NO FAILURES OF THE OUTER TRAY/LID WERE SEEN DURING THE PACKAGING PERFORMANCE VALIDATION, FILE (B)(4). THE PACKAGING PERFORMANCE VALIDATION HAD WORST CASE (ASSURANCE LEVEL I) SIMULATED DISTRIBUTION COMPLETED PER (B)(4). REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES FOR THIS LOT. RELAYED COMPLETION OF THE INVESTIGATION TO THE SALES REP VIA EMAIL ON (B)(6) 2015. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR ITEM: (B)(4), LOT: 140960, COMBINATION. IN ADDITION, THERE WERE NO OTHER COMPLAINTS REPORTED FOR ITEM: (B)(4) AND COMPLAINT CATEGORY: PACKAGING: DAMAGED STERILE PACKAGING. 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 PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON OCTOBER 23, 2014. DURING THE PROCEDURE, AN IMPLANT WAS DISCOVERED TO HAVE A CRACKED CASING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775817 VNGD CR TIB BRG 10X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 140960

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR