BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ B LM PMA

    MDR report key: 15500358 · Received September 28, 2022

    Report

    Report Number
    3002806535-2022-00406
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    August 31, 2022
    Report Date
    November 21, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388868
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#:161469; LOT#: UNKNOWN; ITEMNAME: OXF TWIN-PEG CMNTD FEM MD PMA; ITEM#:159548; LOT#: UNKNOWN; ITEMNAME: OXF ANAT BRG LT MD SIZE 4 PMA. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 -2022 -00407, 3002806535 -2022 -00409.

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). D10: ITEM#:161469; LOT#: 813400; ITEMNAME: OXF TWIN-PEG CMNTD FEM MD PMA; ITEM#:159548; LOT#: 3063641; ITEMNAME: OXF ANAT BRG LT MD SIZE 4 PMA THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D10, G3, G6, H2, H4, H6, H10. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN UNKNOWN REASON. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077569 OXF UNI TIB TRAY SZ B LM PMA PROSTHESIS, KNEE, FEMOROTIBIAL NRA BIOMET UK LTD. N/A 645800 05019279388868

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 COMMENTS| SEE H10 NARRATIVE.