BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 3 PMA MED SZ 3

    MDR report key: 8820901 · Received July 24, 2019

    Report

    Report Number
    3002806535-2019-00613
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    January 1, 2019
    Report Date
    September 25, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). X-RAY REVIEW: THE QUALITY OF THE PROVIDED RADIOGRAPH MAKES IT DIFFICULT TO COMMENT ON THE SIZING, FIT AND ALIGNMENT OF COMPONENTS. OSTEOPHYTES OR FRAGMENTS OF BONE OR BONE CEMENT ARE VISIBLE BOTH ANTERIORLY AND POSTERIORLY IN THE JOINT SPACE, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED PAIN AND INSTABILITY. 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 PATIENT UNDERWENT INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED THE ONSET OF CONSTANT SEVERE PAIN WITH SOME INSTABILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA EM MED CATALOG #: 161469 LOT #: 2234847, MEDICAL PRODUCT: OXF UNI TIB TRAY SZ D LM PMA CATALOG #: 154724 LOT #: 2423707. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00612, 3002806535-2019-00614. 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 PATIENT UNDERWENT INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED THE ONSET OF CONSTANT SEVERE PAIN WITH SOME INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617610 OXF ANAT BRG LT MD SIZE 3 PMA MED SZ 3 KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 125140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization