BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 7CM SEG ELLIPT FEMORAL RT

    MDR report key: 9339197 · Received November 18, 2019

    Report

    Report Number
    0001825034-2019-05259
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    December 12, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO HYPEREXTENSION WITH HARD METAL STOP OF THE PROSTHESIS, DUE TO POSSIBLE MALFUNCTION OF THE COUPLING MECHANISM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: 2015. CONCOMITANT MEDICAL PRODUCTS: 150410, 150410, S TIBIAL POLY BEARING 12MM. 150393, 852780, OSS POROUS IM STEM 14.5 X 150. 150448, 146530, OSS POR STRAIGHT STEM 10.5X150. 150443, 719450, OSS MOD PROX TIB 9CM M. 150493, 097220, OSS REINFORCED YOKE. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05260.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED HYPEREXTENSION WITH HARD METAL STOP OF THE PROSTHESIS, APPROXIMATELY FOUR YEARS POST IMPLANTATION, DUE TO POSSIBLE MALFUNCTION OF THE COUPLING MECHANISM. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128646 OSS 7CM SEG ELLIPT FEMORAL RT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 449990

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R