BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI CMNTLS TIB SZ E LM

    MDR report key: 8779621 · Received July 11, 2019

    Report

    Report Number
    3002806535-2019-00601
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: OXFORD PH3 CEMENTLESS FEM SZ L PC/HA, CATALOG #: 154927, LOT #: 2957707; OXF PKS ANAT MEN BRG UHMWPE LT LRG SZ 4, CATALOG #: 159555, LOT #: 2860868. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00600, 3002806535-2019-00602. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576166 OXF UNI CMNTLS TIB SZ E LM KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2160383

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Congenital Anomaly| H