BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT LG SIZE 3 PMA

    MDR report key: 11824318 · Received May 14, 2021

    Report

    Report Number
    3002806535-2021-00198
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786008
    PMA / PMN Number
    P01004
    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). INITIAL FINAL COMBINED REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ F LM PMA, CATALOG #: 154775, LOT #: 828320; MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG #: 161470, LOT #: 612410. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00196, 3002806535-2021-00197. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 COMPLAINT REPORTED WITH THE ITEM 154775, 1 COMPLAINT REPORTED WITH THE ITEM 161470, AND 2 COMPLAINT REPORTED WITH THE ITEM 159554 INCLUDING INITIATING COMPLAINT. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2017. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720822 OXF ANAT BRG LT LG SIZE 3 PMA OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A 348010 05019279786008

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R