BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT X-SM SZ 5 PMA

    MDR report key: 8001182 · Received October 24, 2018

    Report

    Report Number
    3002806535-2018-01156
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 24, 2018
    Report Date
    January 29, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO LATERAL COMPARTMENT COLLAPSE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - OXF UNI TIB TRAY SZ B LM PMA, ITEM 154720, LOT 317790. OXF TWIN-PEG CMNTD FEM XS PMA, ITEM 161467, LOT 3021395. THERAPY DATE - (B)(6) 2018. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01154 AND 3002806535-2018-01155.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO LATERAL COMPARTMENT COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840531 OXF ANAT BRG LT X-SM SZ 5 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. 85320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R