BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING

    MDR report key: 10216041 · Received June 30, 2020

    Report

    Report Number
    0001825034-2020-02548
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B2, B3, B4, B5, D6, D7, E1, G4, G7, H1, H2, H3, H6, H10. CORRECTION: D1, D2, D4, D11, G5, H4. D11: MEDICAL DEVICE: BIOMET FINNED PRI STEM 40MM CATALOG # 141314 LOT # 827800. VANGUARD CR POR FMRL-LT 65 CATALOG # 183068 LOT # 552060. BIOMET ILOK PRI TIB TRAY 67MM CATALOG # 141212 LOT # 631510. COBALT-G HV BONE CEMENT 40GM B CATALOG # 402433 LOT # 318670. 1/8 QWIKRELES DRL STERILE PK2 CATALOG # 32-486265 LOT # 237340. 1/8 QWIKRELES DRL STERILE PK2 CATALOG # 32-486265 LOT # 237340. DIAMOND V STRYKR 2000 25.4X85 CATALOG # 516051 LOT # 126225. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THAT THE PRESUMED LEFT KNEE (NO INDICATION ON THE ANNOTATIONS TO INDICATE WHICH IS ACTUALLY THE LEFT KNEE), THE ALIGNMENT, FIT AND BONE QUALITY APPEAR NORMAL. A PRESUMED RIGHT KNEE DEMONSTRATES JOINT SPACE LOSS IN THE LATERAL COMPARTMENT WHICH COULD BE RELATED TO POLY WEAR. FURTHER MEDICAL RECORDS WERE 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

    FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY AND WEAR.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WILL BE CONSIDERED FOR REVISION DUE TO WEAR CAUSING INSTABILITY. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679975 VANGUARD DCM CR TIBIAL BEARING PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 526550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R SEE H10 NARRATIVE