BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZA LM

    MDR report key: 15507310 · Received September 29, 2022

    Report

    Report Number
    3002806535-2022-00403
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 12, 2022
    Report Date
    November 14, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388844
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS; LPS OPTION FEMORAL E-L , ITEM# 00-5996-015-51 , LOT# 63742529, ST PRC TIB PLT SIZE 5 , ITEM# 00-5980-047-01 , LOT# J6828721, LPS FLEX ART SURF EF5 6 14 , ITEM# 00-5962-040-14 , LOT# 64971772, STEM IMPLANT 15MMDX75MM. ITEM# 00-5988-012-15 , LOT# 64946296, ALL POLY PAT COMP 32DIA , ITEM# 00-5972-065-32 , LOT# 65341199, OXF TWIN-PEG CMNTD FEM MD PMA , ITEM# 161469 , LOT# 266810, OXF ANAT BRG LT MD SIZE 4 PMA , ITEM# 159548 , LOT# 403220. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, 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. DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 A REVISION SURGERY DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE 3 YEARS POST-IMPLANTATION. PATIENT WAS REVISED TO PRIMARY TKA. 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
    1634966 OXF UNI TIB TRAY SZA LM KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 150470 05019279388844

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE