BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM- PS OPEN INTL FEM-LT 75

    MDR report key: 6664474 · Received June 23, 2017

    Report

    Report Number
    0001825034-2017-04295
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    November 16, 2016
    Report Date
    December 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS- BIOMET CC CRUCIATE TRAY CATALOG #: 141236 LOT #: J3164690. 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 REPORT: 0001825034-2017-04300. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: SERIES-A STANDARD PATELLA, CATALOG #: 184766 LOT #: 914120, VANGUARD TIBIAL BEARING, CATALOG #: EP-183660 LOT #: 644360. 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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED OP NOTES. 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. SURGICAL NOTES WERE PROVIDED FOR THE REVISION SURGERY. REVIEW OF THE REVISION OPERATIVE NOTES INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS. THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE PATIENT'S CONDITION AS PATIENT HAS A CONFIRMED METAL ALLERGY. 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 BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTIES APPROXIMATELY THREE YEARS AGO. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO PAIN, EFFUSIONS AND METAL ALLERGIES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443859 VANGUARD COMPLETE KNEE SYSTEM- PS OPEN INTL FEM-LT 75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 060840

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R SEE NARRATIVE IN H10