BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS COCR SIZE B LM STD

    MDR report key: 6549627 · Received May 5, 2017

    Report

    Report Number
    3002806535-2017-00282
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    April 5, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXFORD PKS FEMORAL COCR MEDIUM, CATALOG #: 154601. LOT #: 1091989; AND OXF ANAT BRG LT MD SIZE 5 PMA, CATALOG #: 159549, LOT #: 925893. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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 REPORT: 3002806535-2017-00281.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM 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 · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO LOOSENING/MALALIGNMENT. ALL COMPONENTS WERE REMOVED AND REPLACED WITH TOTAL KNEE IMPLANTS. 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
    330182 OXFORD PKS COCR SIZE B LM STD PROSTHESIS, KNEE NRA BIOMET UK LTD. 898411

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R