BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM SERIES-A PATELLA

    MDR report key: 6970628 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09584
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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). CONCOMITANT MEDICAL PRODUCTS: BIOMET CC CRUCIATE TRAY 71MM, CATALOG # 141233, LOT # J3428971 VANGUARD PS TIBIAL BEARING, CATALOG # 183640, LOT # 614890 VANGUARD PS INTLK RIGHT FEMORAL 67.5, CATALOG # 183210, LOT # 571000 SIGNATURE TKA GUIDE/MDL SET, CATALOG # 42-422551, LOT # 133581. 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: 0001825034-2017-06164, 0001825034-2017-06165, 0001825034-2017-06166, 0001825034-2017-09584. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED UNDERGOING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY USING CUSTOM GUIDES. THE PATIENT FURTHER REPORTED EXPERIENCING RIGHT KNEE PAIN, LIMITED RANGE OF MOTION, INSTABILITY, AND SWELLING 2 YEARS POST-IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS SUFFERING FROM PAIN, LIMITED RANGE OF MOTION, INSTABILITY AND SWELLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749857 ARCOM SERIES-A PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 299150 

    Patients

    Seq Age Sex Outcome Treatment
    1 Other