BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 11788965 · Received May 7, 2021

    Report

    Report Number
    3002806535-2021-00166
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 21, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH 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. NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00165-1, 3002806535-2021-00163-1. 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. DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT HAS BEEN DISCARDED. MEDICAL PRODUCT: UNK OXFORD FEMORAL COMPONENT, CATALOG #: UNK, LOT #: UNK. MEDICAL PRODUCT: UNK OXFORD BEARING COMPONENT, CATALOG #: UNK, LOT #: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00163, 3002806535-2021- 00165 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 LEFT KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2018. 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
    689464 UNKNOWN OXFORD TIBIAL COMPONENT KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R