BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUS TI POR 59 360 TIB TRAY

    MDR report key: 8573249 · Received May 2, 2019

    Report

    Report Number
    0001825034-2019-02019
    Event Type
    Injury
    Date Received
    May 2, 2019
    Report Date
    January 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, IT WAS CONFIRMED A SCREW FOR THE OFFSET ADAPTER CONTAINS NICKEL. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). CONCOMITANT MEDICAL PRODUCTS: 148291 - BMT SPLINED KNEE STM V2 16X40 ¿ 999910; 141355 - RGX 3 PEG SER A PATELLA 28MM ¿ 528570; 148301 - BMT SPLINED KNEE STM V2 11X80 ¿ 739010; 183808 - VNGD SSK PSC TIB BRG SM 18X59 ¿ 546740; 185536 - VG 360 OTI TIB SLV SM HALF B ¿ 602200; CP116182 - TI P AUG 57.5 RT 360 FMRL ¿ 117060; 185212 - BMT 360 7.5MM OFFSET ADAPTER - 947060/ CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT 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 -02013, 0001825034 -2019 -02014, 0001825034 -2019 -02015, 0001825034 -2019 -02016, 0001825034 -2019 -02017, 0001825034 -2019 -02018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PAIN, BURNING, AND DIFFICULTY AMBULATING APPROXIMATELY 3 YEARS AFTER KNEE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366295 CUS TI POR 59 360 TIB TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 117070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other