BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZA RM/LL PMA

    MDR report key: 8455106 · Received March 27, 2019

    Report

    Report Number
    3002806535-2019-00298
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 20, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT SUFFERED PULMONARY EMBOLUS IN BOTH LUNGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT SUFFERED PULMONARY EMBOLUS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS INITIALLY REPORTED UNDER BIOMET ORTHOPEDICS LLC FACILITY NUMBER, REPORT REFERENCE: 0001825034-2019-01277. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535 -2019 - 00299, 3002806535 -2019 - 00300. CONCOMITANT MEDICAL PRODUCTS: OXF TWIN-PEG CMNTD FEM SM PMA ITEM# 161468 LOT# 790270, OXF ANAT BRG RT SM SIZE 3 PMA ITEM# 159568 LOT# 428720. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT SUFFERED PULMONARY EMBOLUS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248869 OXF UNI TIB TRAY SZA RM/LL PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2154719

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R