BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET ARCOM 3-PEG PATELLA

    MDR report key: 7759107 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06460
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    January 29, 2007
    Report Date
    September 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES ¿ VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT LEFT 55, CATALOG #: 183020, LOT #: NI; VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 10X63, CATALOG #: 189020, LOT #: NI; BIOMET CC I-BEAM TIBIAL TRAY 63MM, CATALOG #: 141221, LOT #: NI. IT IS INDICATED BY THE COMPLAINANT THAT THE DEVICES WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES 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 EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06457, 0001825034-2018-06458, 0001825034-2018-06459. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED A BAKER¿S CYST FIVE (5) MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598959 UNKNOWN BIOMET ARCOM 3-PEG PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other