BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA FIXED NON-POROUS LEFT SIZE F

    MDR report key: 11170172 · Received January 14, 2021

    Report

    Report Number
    0001822565-2021-00163
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024562806
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-00164-1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TIBIAL IMPLANT LOOSENING SECONDARY TO TIBIAL IMPLANT DISASSOCIATION AT THE STEM JUNCTION AND MEDIAL PROXIMAL TIBIAL BONE FRACTURE. COMPLAINT IS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS FOR TIBIAL PLATE IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT, LOOSENING AND BONE FRACTURE ARE KNOWN ADVERSE EFFECTS OF THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED PRODUCTS : ITEM#: 42560113512; STEM EXTENSION STRAIGHT SPLINED UNCEMENTED 12 MM DIAMETER +135 MM LENGTH; LOT#:UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2021 - 00164.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY 2 MONTHS POST-OP DUE TO STEM DISASSOCIATION FROM THE TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68854 TIBIA FIXED NON-POROUS LEFT SIZE F PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64495996 00889024562806

    Patients

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