BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK OXFORD FEMORAL COMPONENT

    MDR report key: 11751239 · Received April 30, 2021

    Report

    Report Number
    3002806535-2021-00144
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: BIOMET UK LTD HAVE ATTEMPTED TO CONTACT SALES REPRESENTATIVE, HOWEVER, WE HAVE NOT BEEN ABLE TO RETRIEVE ANY FURTHER INFORMATION RELEVANT TO THIS COMPLAINT. THE PRODUCT HAS NOT BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION, THEREFORE, A THOROUGH INVESTIGATION HAS NOT BEEN POSSIBLE. IN ADDITION, 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, 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: 3002806535-2021-00142-1, 3002806535-2021-00143-1. 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 NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF AN OXFORD MOBILE BEARING IMPLANT OCCURRED. THE REVISION WAS DUE TO DISLOCATION AND MEDIAL TIBIAL PLATEAU COLLAPSE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: UNK OXFORD BEARING COMPONENT, CATALOG #: UNK, LOT #: UNK. MEDICAL PRODUCT: UNK OXFORD TIBIAL COMPONENT, CATALOG #: UNK, LOT #: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00142, 3002806535-2021-00143. 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 REVISION OF AN OXFORD MOBILE BEARING IMPLANT OCCURRED. THE REVISION WAS DUE TO DISLOCATION AND MEDIAL TIBIAL PLATEAU COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652672 UNK OXFORD FEMORAL COMPONENT KNEE ARTHROPLASTY JWH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R