BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 10360791 · Received August 4, 2020

    Report

    Report Number
    3002806535-2020-00353
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    June 17, 2020
    Report Date
    September 4, 2020
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00354-1, 3002806535-2020-00355-1. 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. A REVIEW OF THE MANUFACTURING HISTORY COULD NOT BE PERFORMED AS ITEM NUMBERS AND LOT NUMBERS ARE UNKNOWN. COMPLAINT HISTORY SEARCH COULD NOT BE PERFORMED AS ITEM NUMBERS AND LOT NUMBERS ARE UNKNOWN. RISK ASSESSMENT: 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. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO FAILED TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN OXFORD FEMORAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. UNKNOWN OXFORD BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00354, 3002806535-2020-00355. 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) 2019. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO FAILED TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825701 UNKNOWN OXFORD TIBIAL COMPONENT UNKNOWN KNEE ARTHROPLASTY JWH BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R