BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS CEMENTED TIBIA, ALPHA, STANDARD - LM SIZE B

    MDR report key: 14561378 · Received June 1, 2022

    Report

    Report Number
    3002806535-2022-00260
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388868
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: OXF ANAT BRG LT SM SIZE 3 PMA ITEM#159540 LOT#075460; OXF TWIN-PEG CMNTD FEM SM PMA ITEM#161468 LOT#953870; BIOMET BONE CEMENT R 1X40US ITEM#110035368 LOT#005FAE2408 . THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A REVISION DUE TO THE LOOSENING AND PAIN OF THE LEFT KNEE, APPROXIMATELY ONE YEAR POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO FURTHER EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933627 OXFORD PKS CEMENTED TIBIA, ALPHA, STANDARD - LM SIZE B OXFORD CEMENTED TIBIAL TRAYS NRA BIOMET UK LTD. N/A 783570 05019279388868

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE