BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TIBIAL TRAY COMPONENT

    MDR report key: 8175691 · Received December 18, 2018

    Report

    Report Number
    0001822565-2018-06943
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 30, 2018
    Report Date
    October 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. PER THE INSTRUCTIONS FOR USE OF THE DEVICES, INFECTION IS A KNOWN POTENTIAL ADVERSE EFFECTS OF THE TOTAL KNEE ARTHROPLASTY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THE LOT NUMBER FOR THIS COULD BE EITHER LOT 63714960 OR LOT 63701355 IT IS UNCLEAR AT THIS TIME WHICH IS THE EXACT PRODUCT USED AS THE IMPLANT HAS BEEN DISCARDED AND THE PATIENT HAD A BI-LATERAL PROCEDURE WITH NO ISSUES WITH THE LEFT KNEE. (P/N:00595405701, L/N:63714960) NEXGEN MIS TM TIB SZ 7, MFG DATE: 07/31/2017, EXP DATE: 07/31/2027, MFG SITE: (B)(4). (P/N:00595405701, L/N:63701355) NEXGEN MIS TM TIB SZ 7, MFG DATE: 06/28/2017, EXP DATE: 06/30/2027, MFG SITE: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00-5952-017-02, LOT 63573639 CR-FLEX POROUS FEM G-RIGHT, 00-5952-050-12, LOT 62762927 XLPE DR-FLEX ART SURF CH 7-10/BLU 12, 00-5952-050-14, LOT 63114461 XLPE DR-FLEX ART SURF CH 7-10/BLU 14.

    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). CONCOMITANT MEDICAL PRODUCTS: NEXGEN-FEMORAL, ITEM # UNKNOWN, LOT # UNKNOWN. NEXGEN-BEARING, ITEM # UNKNOWN, LOT # UNKNOWN. UNKNOWN SCREWS. FOREIGN - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT HAS BEEN DISCARDED. 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: 0001822565-2018-06944, 0001822565-2018-06945, 0001822565-2018-06989. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION. "DEBRIDMENT" SYNOVECTOMY WAS ALSO PERFORMED. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC CEMENT SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013262 NEXGEN TIBIAL TRAY COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R