BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 9615556 · Received January 22, 2020

    Report

    Report Number
    3002806535-2020-00036
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 22, 2020
    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). A REVIEW OF THE COMPLAINT IDENTIFIED THAT THE FEMORAL COMPONENT BELOW WAS NOT REPORTABLE, AND THEREFORE MOVED TO AN ASSOCIATED PRODUCT. SUBSEQUENTLY, WE ARE VOIDING THIS MEDWATCH REPORT: MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA, CATALOG #: 161469, LOT #: 800730.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A THE BEARING WAS REVISED DUE TO DISLOCATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF ANAT BRG LT MD SIZE 5 PMA, CATALOG #: 159549, LOT #: 561850, MEDICAL PRODUCT: OXF UNI TIB TRAY SZ D LM PMA, CATALOG #: 154724, LOT #: 342130, MEDICAL PRODUCT: 1/8 QUICK REL DRL STERILE 2PK, CATALOG #: 32-486265, LOT #: 765430, MEDICAL PRODUCT: STRYKER OP RCP 76.0X11.7, CATALOG #: 277325, LOT #: 313706, MEDICAL PRODUCT: STRYK_76542K_13X90X.89F, CATALOG #: 13-0900-89Y-F1, LOT #: 313261. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00034, 3002806535-2020-00035. 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 THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO BEARING DISLOCATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77878 OXF TWIN-PEG CMNTD FEM MD PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 800730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R