BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SERIES-A STANDARD PATELLA ARCOM THREE 1/4" PEGS

    MDR report key: 6549466 · Received May 5, 2017

    Report

    Report Number
    0001825034-2017-03117
    Event Type
    Injury
    Date Received
    May 5, 2017
    Report Date
    August 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCT: E1 VANGUARD PS TIBIAL BEARING 79/83X16 MM, ITEM #: EP-183666, LOT #: 545870; VANGUARD TM PS OPEN BOX FEMORAL - 72.5 MM LEFT-INTERLOK, ITEM #: 183133, LOT #: 642900; BIOMET FIXED I-BEAM TIBIAL PLATE INTERLOK - WITH LOCKING BAR, ITEM #: 141225, LOT #: J3691161. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL CURRENTLY IMPLANTED. THE INVESTIGATION IS CURRENTLY 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: 0001822565-2017-03055, 0001825034-2017-03118, 0001825034-2017-03119.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT IS EXPERIENCING ONGOING PAIN. WHEN EVALUATED BY HIS PHYSICIAN, HE WAS TOLD THAT EVERYTHING WAS NORMAL AND HE WAS DISMISSED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330696 VANGUARD SERIES-A STANDARD PATELLA ARCOM THREE 1/4" PEGS KNEE, PROSTHESIS JWH BIOMET ORTHOPEDICS N/A 403740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention