BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM SM PMA

    MDR report key: 8490514 · Received April 8, 2019

    Report

    Report Number
    3002806535-2019-00353
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    February 19, 2019
    Report Date
    August 19, 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
    NC, 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D2, D4, D11, G4, G5, G7, H1, H2, H3, H4, H6, H10. D11: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ C LM PMA ITEM #:154722 LOT #:803140. MEDICAL PRODUCT: OXF ANAT BRG LT SM SIZE 4 PMA ITEM #:159541 LOT #: 341460. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 A PATIENT WAS REVISED DUE TO FEELING UNSTABLE.

    Description of Event or Problem · 0

    LEFT KNEE REVISION DUE TO UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO FEELING UNSTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN OXFORD TIBIAL COMPONENT, CATALOG #: NOT REPORTED, LOT #: NOT REPORTED. MEDICAL PRODUCT:UNKNOWN OXFORD BEARING, CATALOG #: NOT REPORTED, LOT #: NOT REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00352 , 3002806535-2019-00354. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    LEFT KNEE REVISION DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286031 OXF TWIN-PEG CMNTD FEM SM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 566740

    Patients

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