BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM SERIES A STANDARD PATELLA

    MDR report key: 7618222 · Received June 20, 2018

    Report

    Report Number
    0001825034-2018-04139
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    April 11, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR TIBIAL BEARING; CATALOG#: 183448; LOT#: NI. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03140, 0001825034-2018-04139. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462938 ARCOM SERIES A STANDARD PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R