BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK OXFORD FEMORAL COMPONENT

    MDR report key: 9928132 · Received April 6, 2020

    Report

    Report Number
    3002806535-2020-00215
    Event Type
    Injury
    Date Received
    April 6, 2020
    Report Date
    July 16, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00214-1. THE PRODUCT HAS NOT BEEN RETURNED TO BIOMET FOR EVALUATION, THEREFORE, A THOROUGH INVESTIGATION HAS NOT BEEN POSSIBLE. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE PRODUCT AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. 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. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY H3 OTHER TEXT: PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2018. SUBSEQUENTLY, APPROXIMATELY ONE YEAR POST OP PATIENT STARTED TO EXPERIENCE INCREASING PAIN, DIFFICULTY WALKING, INSTABILITY, AND CLUNKING NOISE AND FEELING. SURGEON HAS DIAGNOSED PATIENT WITH MECHANICAL LOOSENING. PATIENT IS SCHEDULED FOR REVISION TO TOTAL KNEE (B)(6) 2020.

    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. MEDICAL PRODUCT: UNKNOWN TIBIAL COMPONENT, CATALOG # UNKNOWN, LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00214. 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 PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2018. SUBSEQUENTLY, APPROXIMATELY ONE YEAR POST OP PATIENT STARTED TO EXPERIENCE INCREASING PAIN, DIFFICULTY WALKING, INSTABILITY, AND CLUNKING NOISE AND FEELING. SURGEON HAS DIAGNOSED PATIENT WITH MECHANICAL LOOSENING. PATIENT IS SCHEDULED FOR REVISION TO TOTAL KNEE (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391485 UNK OXFORD FEMORAL COMPONENT KNEE PROTHESIS JWH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE - H10.