BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET BEARING

    MDR report key: 8531592 · Received April 19, 2019

    Report

    Report Number
    0001825034-2019-01780
    Event Type
    Injury
    Date Received
    April 19, 2019
    Report Date
    August 29, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES OR MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: UNKNOWN DATE IN (B)(6) 2019. CONCOMITANT MEDICAL PRODUCT: VANGUARD SSK INTERLOK FEMORAL, CATALOG #: 183302, LOT #: UNK; UNKNOWN BIOMET BEARING, CATALOG #: UNK, LOT #: UNK; UNKNOWN BIOMET TIBIAL TRAY, CATALOG #: UNK, LOT #: UNK. CUSTOMER HAS INDICATED PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01770, 0001825034-2019-01781. 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT ALLEGES THAT A MANIPULATION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE; HOWEVER, THERE HAS BEEN NO RELIEF. FURTHER THE PATIENT ALLEGES CONTINUOUS PAIN AND A LIMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324361 UNKNOWN BIOMET BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R