BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CRUCIATE RETAINING E1 ANTIOXIDANT INFUSED TIBIAL BEARING 12MM X 71/75MM

    MDR report key: 8276907 · Received January 25, 2019

    Report

    Report Number
    0001825034-2019-00335
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. X-RAYS PROVIDED IDENTIFIED THAT THE OVERALL FIT AND ALIGNMENT OF THE IMPLANTS APPEARED ANATOMIC. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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

    IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED STIFFNESS IN THE LEFT KNEE APPROXIMATELY TWO AND A HALF YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT¿S SURGEON BELIEVES THE PATIENT MAY REQUIRE A MANIPULATION TO ADDRESS THE REPORTED STIFFNESS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED RELEVANT TO THIS COMPLAINT. INITIAL OPERATIVE NOTES WERE PROVIDED, WHICH DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS OR SIGNIFICANT FINDINGS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES - VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT LEFT 65MM, CATALOG #: 183028, LOT #: J3720511; BIOMET CC I-BEAM TIBIAL TRAY 71MM, CATALOG #: 141223, LOT #: J3716585; BIOMET ARCOM PATELLA 34MM, CATALOG #: 11-150828, LOT #: 090920; PALACOS RG 1X40 SINGLE BONE CEMENT, CATALOG #: 00111314001, LOT #: 81484445. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES IN QUESTION REMAIN IMPLANTED. 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 PATIENT, PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2019-00334. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED STIFFNESS IN THE LEFT KNEE APPROXIMATELY TWO AND A HALF YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT¿S SURGEON BELIEVES THE PATIENT MAY REQUIRE A MANIPULATION TO ADDRESS THE REPORTED STIFFNESS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71273 VANGUARD CRUCIATE RETAINING E1 ANTIOXIDANT INFUSED TIBIAL BEARING 12MM X 71/75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 387780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other