BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM SERIES A PAT W/WR STD 31 1 PEG

    MDR report key: 11968592 · Received June 9, 2021

    Report

    Report Number
    0001825034-2021-01747
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES : BIOMET CC CRUCIATE TRAY 79MM, CATALOG: #141235, LOT: #475040, VNGD PS OPEN INTL FEM RT 75, CATALOG: #183114, LOT: #488570. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PHOTOGRAPHS PROVIDED CONFIRMS PATELLA PEG IS FRACTURED OFF THE DEVICE. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THIS DEVICE IS USED FOR TREATMENT. NO COMPATIBILITY ISSUES WERE NOTED. NO MEDICAL RECORDS WERE PROVIDED. X-RAYS WERE PROVIDED BUT NOT SENT FOR REVIEW. POLY IS NOT VISIBILE ON X-RAY AND WOULD LIKELY NOT ENHANCE INVESTIGATION. ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THIS COMPLAINT IS CONFIRMED. 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 THE PS POLY POST WAS BROKEN. PATIENT STATED TURNING OVER IN BED AND HEARING A POPPING. PATIENT WAS REVISED MIDYEAR 2021. ATTEMPTS HAVE BEEN MADE, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865715 ARCOM SERIES A PAT W/WR STD 31 1 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 792970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other