BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET PATELLA 1/4 INCH PEG

    MDR report key: 7307462 · Received March 1, 2018

    Report

    Report Number
    0001825034-2018-01603
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    August 18, 2017
    Report Date
    March 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 62.5 ITEM#183006 LOT#J6006473, VNGD ANT STAB BRG 13X71 LOT#890670 ITEM#189063, BIOMET CC I-BEAM TRAY 71MM LOT#J080209 ITEM#141223. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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: 0001825034-2018-00649, 0001825034-2018-00651, 0001825034-2018-00650.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A PULMONARY EMBOLISM ONE WEEK FOLLOWING INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150172 BIOMET PATELLA 1/4 INCH PEG KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 588380

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention