BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL BEARING

    MDR report key: 7756447 · Received August 7, 2018

    Report

    Report Number
    0001822565-2018-04229
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    April 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UDI # (B)(4). BONE CEMENT LOT# RMX186 QTY: 2 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. SURGICAL NOTES WERE NOT PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    IT WAS FURTHER REPORTED THE PATIENT ALLEGES POSSIBLE ALLERGIC REACTION TO METAL COMPONENTS. THE PATIENT WAS GOING TO HAVE A METAL ALLERGY TEST CONDUCTED. HOWEVER, NO RESULTS HAVE BEEN RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: VAN PS OPEN INTL FEM-LT 75, CATALOG # 183134, LOT # 334550. BIOMET CC CRUCIATE TRAY, CATALOG # 141235, LOT # J3946008. SERIES A PAT THIN 37X8.6 3 PEG, CATALOG # 184788, LOT # 935580. BONE CEMENT, LOT# RMX186. 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: 0001822565-2018-04093, 0001822565-2018-04092, 0001822565-2018-04091. 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 PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY IS NOW EXPERIENCING PAIN AND SWELLING THAT HAS NEVER GONE DOWN. DURING PHYSICAL THERAPY PATIENT EXPERIENCES GRINDING AND POPPING SOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600582 VANGUARD TIBIAL BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 160060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R