BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN FEMORAL COMPONENT PRECOAT SIZE G RIGHT

    MDR report key: 12036624 · Received June 21, 2021

    Report

    Report Number
    3007963827-2021-00136
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND THE OUTER CARTON IS CRUSHED, AND BOTH THE INNER AND OUTER STERILE BLISTERS ARE CRACKED. STERILITY HAS BEEN BREACHED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED BOTH THE INNER PACKAGE WAS BREACHED. IMPLANT WAS CONSIDERED UNSTERILE. ATTEMPTS HAVE BEEN MADE, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933050 NEXGEN FEMORAL COMPONENT PRECOAT SIZE G RIGHT PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62622329

    Patients

    Seq Age Sex Outcome Treatment
    1