BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 9580374 · Received January 13, 2020

    Report

    Report Number
    3002806535-2020-00015
    Event Type
    Injury
    Date Received
    January 13, 2020
    Report Date
    March 5, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P01004
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT: UNKNOWN OXFORD BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNKNOWN OXFORD TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00016-1, 3002806535-2020-00017-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE ITEM NUMBER AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT AND WITHOUT ADEQUATE INFORMATION RECEIVED REGARDING THE EVENT, ROOT CAUSE COULD NOT BE DETERMINED AND THEREFORE RISK COULD NOT BE ASSESSED AGAINST OCCURRENCE OR ANY NEW PREVIOUSLY UNIDENTIFIED RISK. 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNKNOWN OXFORD TIBIAL COMPONENT, CATALOG #: UNKNOWN , LOT #: UNKNOWN, MEDICAL PRODUCT: UNKNOWN OXFORD BEARING CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00017, 3002806535-2020-00016. 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 BY THE PATIENT THAT SHE UNDERWENT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46021 UNKNOWN OXFORD FEMORAL COMPONENT KNEE PROTHESIS NRA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R