BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 9817045 · Received March 11, 2020

    Report

    Report Number
    3002806535-2020-00134
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 19, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G4, H1, H2, H3, H6, H10 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020- 000135-13002806535-2020-00136-1 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 LOT NUMBER IS UNKNOWN. A REVIEW OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED AS ITEM NUMBER IS UNAVAILABLE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNKNOWN OXFORD FEMORAL 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: 3002806535-2020-00135 3002806535-2020-00136. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282721 UNKNOWN OXFORD TIBIAL COMPONENT KNEE PROTHESIS HRY BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R