BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIAL BEARING

    MDR report key: 9335369 · Received November 18, 2019

    Report

    Report Number
    0001825034-2019-05217
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    February 5, 2018
    Report Date
    February 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: SERIES A PAT THN 34 3 PEG; P/N: 184786, L/N: 221300. VANGUARD CR TIB BRG 11X63/67; P/N: CP103404, L/N: 589310. VANGUARD CR POR FEM-RT 60; P/N: 183044, L/N: 930170. BIOMET CC CRUCIATE TRAY 67MM; P/N: 141232, L/N: 948200. COBALT G-HV BONE CEMENT 40G; P/N: 402283, L/N: 007960. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05242 - 1; 0001825034 - 2019 - 05217 - 1; 0001825034 - 2019 - 05219 - 1; 0001825034 - 2019 - 05220 - 1.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED VIA OP-NOTES AND THE REPORTED EVENT WAS NOT CONFIRMED. PRIMARY SURGERY NOTES INDICATE NO INTRA-OPERATIVE COMPLICATIONS. REVISION SURGERY NOTES STATE THAT ALL COMPONENTS WERE REPLACED WITH COMPETITOR COMPONENTS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE - UNKNOWN MONTH AND DAY IN 2010. CONCOMITANT MEDICAL PRODUCTS: KNE-VANGUARD-SCREWS-UNK; P/N: UNK, L/N: UNK. KNE-VANGUARD-BEARINGS-UNK; P/N: UNK, L/N: UNK. KNE-VANGUARD-FEMORALS-UNK; P/N: UNK, L/N: UNK. KNE-VANGUARD-TIBIAL TRAYS-UNK; P/N: UNK, L/N: UNK. BCM-OTHER-UNKNOWN; P/N: UNK, L/N: UNK. CUSTOMER HAS NOT 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: 0001822565-2019-04558-1, 0001825034-2019-05219, 0001825034-2019-05220. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY AND ALLEGED PAIN, INSTABILITY, CLICKING, SWELLING, AND FALLING OVER TWENTY TIMES. IN ADDITION, THE PATIENT ALLEGES HAVING HAD TWO PROCEDURES DUE TO THE SCREW BECOMING LOST. PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION. ALL PRODUCTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133716 VANGUARD CR TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 589310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R