BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM - TWIN PEG FEMORAL

    MDR report key: 6523320 · Received April 26, 2017

    Report

    Report Number
    3002806535-2017-00255
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    March 22, 2017
    Report Date
    June 2, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - OXF UNI TIB TRAY SZA RM/LL PMA CATALOG #: 154719 LOT #: 800780 AND OXF ANAT BRG RT SM SIZE 4 PMA CATALOG #: 159569 LOT #: 704730. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 3002806535-2017-00256 AND 3002806535-2017-00257.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION DUE TO PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305841 OXFORD PARTIAL KNEE SYSTEM - TWIN PEG FEMORAL PROSTHESIS, KNEE NRA BIOMET UK LTD. 897300

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R