BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW SIZE EF 17 MM HEIGHT

    MDR report key: 10762047 · Received October 30, 2020

    Report

    Report Number
    0001822565-2020-03673
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 1, 2020
    Report Date
    February 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042271
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B2, B4, D1, D4, G4, G7, H2, H4, AND H10.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF BEING IN-VIVO. POST OF THE ARTICULAR SURFACE WAS FRACTURED. THE DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. THE ANALYSIS DETERMINED THAT BEARING SHOWS SIGNS OF POTENTIAL POST-FRACTURE DUE TO FATIGUE OVERLOAD. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. PER PACKAGE INSERT 87-6203-453-23: FRACTURE IS KNOWN ADVERSE EFFECT OF THE SYSTEM. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL DEVICES: ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN FEMORAL COMPONENT, LOT NUMBER: UNKNOWN; ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN TIBIAL COMPONENT, LOT NUMBER: UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A KNEE REVISION DUE TO A FRACTURED ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225889 ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW SIZE EF 17 MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 60550805

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PLEASE SEE H10 NARRATIVE.