BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI CMNTLS TIB SZ AA RM

    MDR report key: 8586391 · Received May 7, 2019

    Report

    Report Number
    3002806535-2019-00434
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 11, 2019
    Report Date
    August 20, 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
    UK
    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

    REVISION OF OXFORD MEDIAL UNI KNEE REPLACEMENT DUE TO PAIN IN PATELLOFEMORAL JOINT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT:OXF ANAT BRG RT X-SM 3MM PMA, CATALOG #: 160790, LOT #: 3805078, MEDICAL PRODUCT: OXF PH3 CEMENTLESS FEM SZ XSM, CATALOG #:154912, LOT #: 3093626. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00435, 3002806535-2019-00436. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    KNEE REVISION DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380157 OXF UNI CMNTLS TIB SZ AA RM KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 3499551

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization