BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP FEMORAL LEFT WITH PEGS

    MDR report key: 6880568 · Received September 20, 2017

    Report

    Report Number
    0001825034-2017-07089
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    December 22, 2016
    Report Date
    November 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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: 0001825034-2017-07090-3, 0001825034-2017-07091-3, 0001825034-2017-07092-3, 0001825034-2017-07093-3.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 195753, VANGUARD XP TIBIAL TRAY, 677680. 195807, VANGUARD XP LEFT LATERAL BEARING, 998780. 195877, VANGUARD XP TIBIAL BEARING, 359540. 184764, VANGUARD SERIES-A STANDARD PATELLA,483590. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07090, 0001825034 - 2017 - 07091, 0001825034 - 2017 - 07092, 0001825034 - 2017 - 07093. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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.

    Additional Manufacturer Narrative · 1

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED UNEXPLAINED PAIN AND WOUND DEHISCENCE FOLLOWING SURGERY. THE WOUND WAS LEFT OPEN AND THEN DRESSED. THE PATIENT RECEIVED ANTIBIOTICS TO TREAT THE WOUND. APPROXIMATELY FORTY DAYS POST-ONSET OF ADVERSE EVENT, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TO HAVE THE STITCH SINUS EXCISED AND THE WOUND CLOSED. THE SURGEON NOTED THAT THE PATIENT'S WOUND DEHISCENCE WAS MOST LIKELY RELATED TO THE PATIENT CONTINUING TO SMOKE. IT WAS FURTHER REPORTED AT APPROXIMATELY THREE MONTHS POST-ONSET OF ADVERSE EVENT, THAT THE WOUND HAD COMPLETELY HEALED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED UNEXPLAINED PAIN AND WOUND DEHISCENCE FOLLOWING SURGERY. THE WOUND WAS LEFT OPEN AND THEN DRESSED. PATIENT CONTINUES TO HAVE ONGOING PAIN APPROXIMATELY ONE YEAR POST-IMPLANTATION. THE PATIENT RECEIVED PHYSIOTHERAPY AND PAIN MEDICATION TO RELIEF THE PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED UNEXPLAINED PAIN AND WOUND DEHISCENCE FOLLOWING SURGERY. THE WOUND WAS LEFT OPEN AND THEN DRESSED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT CONTINUES TO HAVE ONGOING PAIN APPROXIMATELY THREE YEARS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659705 VANGUARD XP FEMORAL LEFT WITH PEGS PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 743450

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R