BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL POROUS COAT/ BOND COAT 62.5MM RIGHT

    MDR report key: 6996418 · Received November 2, 2017

    Report

    Report Number
    0001825034-2017-09750
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    June 7, 2017
    Report Date
    March 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 183640, VNGD PS TIB BRG 10X71/75MM, LOT # 013480. CATALOG #: 141273, BMET REGENX PRI TIB TRAY 71MM, LOT # 277760. CATALOG #: 141314, BIOMET FINNED PRI STEM 40MM, LOT # 818090. CATALOG #: 32-486265, 1/8 QUICK REL DRL STERILE 2PK, LOT # 412170. CATALOG # 141357, RGX 3 PEG SER A PATELLA 34MM, LOT # 165780. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE X-RAYS PROVIDED WERE SENT TO AN HCP FOR REVIEW. FROM THE REVIEW, IT WAS NOTED THAT NO METALLOSIS WAS FOUND IN THE RIGHT KNEE. THE ONLY ABNORMALITIES OF THE RIGHT KNEE INCLUDE OSTEOPENIA AND SMALL EFFUSION. ALL THE COMPONENTS WERE FOUND INTACT AND PROPERLY ALIGNED. THE ADDITIONAL REVIEW IDENTIFIED A PATCHY REGION OF LUCENCY PROXIMAL TO THE ARTICULAR SURFACE OF THE FEMORAL HARDWARE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04787.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS INVESTIGATION REMAINS CLOSED. 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

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT IS CONFIRMED VIA OP NOTES. REVIEW OF OP-NOTES IDENTIFIED GROSSLY LOOSE COMPONENTS AS WELL AS METAL DEBRIS IMPREGNATED INTO THE TIBIAL BEARING AND THE PATELLA BONE. ROOT CAUSE REMAINS UNDETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT WAS NOT REMOVED DURING THE REVISION PROCEDURE. THEREFORE, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DURING THE REVISION IT WAS FOUND THAT THE PATELLA PEGS HAD WORN DOWN AND THAT THERE WAS METALLOSIS. THE SITE WAS CLEANED AND A NEW PALELLA BUTTON IMPLANTED. 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 PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY REVISION APPROXIMATELY FOUR (4) YEARS POST-OPERATIVELY, DUE TO PAIN AND A LOOSE PATELLAR COMPONENT. DURING THE REVISION, METAL DEBRIS WAS NOTED IN THE JOINT SPACE, ALONG WITH METALLOSIS AND SYNOVITIS, AND SOME ETCHING WITHIN THE TROCHLEA. THE PATELLA WAS REMOVED AND REPLACED WITH A CEMENTED COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775803 VANGUARD PS OPEN BOX FEMORAL POROUS COAT/ BOND COAT 62.5MM RIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 036910

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R