BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM PATELLA 3/4 INCH PEGS

    MDR report key: 6843866 · Received September 5, 2017

    Report

    Report Number
    0001825034-2017-06916
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    March 27, 2017
    Report Date
    March 6, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 0001822565-2017-02771. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06918, 0001825034-2017-06919, 0001825034-2017-06920, 0001825034-2017-06921. UDI # (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET VANGUARD COMPLETE KNEE XP FEMORAL COMPONENT CATALOG # 195910 LOT # 162700, BIOMET VANGUARD COMPLETE KNEE XP RIGHT LATERAL BEARING CATALOG# 195774, LOT # 790010, BIOMET VANGUARD COMPLETE KNEE XP RIGHT MEDIAL BEARING CATALOG# 195844, LOT # 529590, BIOMET VANGUARD COMPLETE KNEE XP TIBIAL TRAY CATALOG # 195752, LOT # 065310. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY APPROXIMATELY TWENTY ONE (21) MONTHS AGO AND IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES. THE PATIENT WAS ADVISED TO HAVE A REVISION SURGERY FROM HER SURGEON. 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
    622499 BIOMET ARCOM PATELLA 3/4 INCH PEGS PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 657060

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other