BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR-FLEX PCT FEM G-R MINUS

    MDR report key: 12960174 · Received December 8, 2021

    Report

    Report Number
    3007963827-2021-00313
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 11, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024207080
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET, AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE CARTON EXHIBITS SOME WEAR BUT NO CREASES OR DENTS. BOTH INNER CAVITIES ARE CONFIRMED CRACKED/DAMAGED. STERILITY HAS BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. 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

    IT WAS REPORTED THAT THE INNER AND OUTER PLASTIC PACKAGING WAS CRACKED. IT IS THOUGHT TO BE MOST LIKELY DUE TO THE IMPLANTS BEING WRAPPED TOO TIGHTLY IN THE PACKAGING BUNDLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859517 NEXGEN CR-FLEX PCT FEM G-R MINUS PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63954628 00889024207080

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male