BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN BEARING

    MDR report key: 8173638 · Received December 18, 2018

    Report

    Report Number
    0001822565-2018-06945
    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 ITEM AND LOT NUMBER FOR THIS COULD BE EITHER ITEM 00595205012 LOT 62762927 OR ITEM 00595205014 LOT 63114461 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. ITEM #00595205012, LOT #62762927 XLPE DR-FLEX ART SURF CH 7-10/BLU 12, MFG DATE: 08/12/2014, EXP DATE: 07/31/2019, MFG SITE: (B)(4). ITEM #00595205014, LOT #63114461 XLPE DR-FLEX ART SURF CH 7-10/BLU 14, MFG DATE: 07/27/2015, EXP DATE: 07/31/2020, 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-TIBIAL TRAYS ITEM # UNKNOWN LOT # UNKNOWN, NEXGEN-FEMORAL ITEM # UNKNOWN LOT # UNKNOWN. 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: 0001822565-2018-06943, 0001822565-2018-06944. 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 INITIAL RIGHT KNEE SURGERY SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014743 NEXGEN BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention