BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 11789968 · Received May 7, 2021

    Report

    Report Number
    3002806535-2021-00170
    Event Type
    Injury
    Date Received
    May 7, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. 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 COULD NOT BE PERFORMED AS ITEM NUMBERS AND LOT NUMBERS ARE UNKNOWN. A REVIEW OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED AS ITEM NUMBERS AND LOT NUMBERS ARE UNKNOWN. 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. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00167-1, 3002806535-2021-00169-1. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SIDE IMPLANTATION ON AN UNKNOWN DATE IN 2013. SUBSEQUENTLY, AN ARTHROSCOPY OF THE RIGHT KNEE JOINT WITH PARTIAL RESECTION OF THE INNER MENISCUS, CARTILAGE SMOOTHING AND MICROFRACTURING OF THE MEDIAL TIBIAL PLATEAU WAS PERFORMED DUE TO UNKNOWN REASON ON UNKNOWN DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). WE HAVE REQUESTED THAT THE PRODUCT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: UNKNOWN BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNKNOWN TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00167, 3002806535-2021- 00169. 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 A PATIENT UNDERWENT AN INITIAL RIGHT SIDE IMPLANTATION ON AN UNKNOWN DATE IN 2013. SUBSEQUENTLY, AN ARTHROSCOPY OF THE RIGHT KNEE JOINT WITH PARTIAL RESECTION OF THE INNER MENISCUS, CARTILAGE SMOOTHING AND MICROFRACTURING OF THE MEDIAL TIBIAL PLATEAU WAS PERFORMED DUE TO UNKNOWN REASON ON UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689516 UNKNOWN OXFORD FEMORAL COMPONENT OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R