BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM TWIN PEG FEMORAL

    MDR report key: 6658629 · Received June 21, 2017

    Report

    Report Number
    3002806535-2017-00526
    Event Type
    Injury
    Date Received
    June 21, 2017
    Date of Event
    May 22, 2017
    Report Date
    December 14, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER - (B)(4). UDI # - (B)(4). CONCOMITANT MEDICAL PRODUCTS: - OXF UNI TIB TRAY SZ D RM PMA, CATALOG #: 154725, LOT #: 702910 AND OXF ANAT BRG RT LG SIZE 3 PMA, CATALOG #: 159582, LOT #: 894000. 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: 3002806535-2017-00523 AND 3002806535-2017-00525. PRODUCT LOCATION UNKNOWN.

    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 ONE YEAR POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437708 OXFORD PARTIAL KNEE SYSTEM TWIN PEG FEMORAL PROSTHESIS, KNEE NRA BIOMET UK LTD. 074580

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R