BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA CEMENTED TIBIA

    MDR report key: 20333123 · Received September 30, 2024

    Report

    Report Number
    0001822565-2024-03097
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 1, 2024
    Report Date
    January 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024632165
    PMA / PMN Number
    K221479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. CORRECTION: H4. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW INDICATES THERE IS CELLULITIS WITH INCREASED SWELLING SECONDARY TO INCREASED ACTIVITY, MODERATE SEVERITY; THE REDNESS WAS AROUND THE KNEE MORE MEDIAL AND DOWN AROUND THE CALF. THE SWELLING AND CELLULITIS WAS NOTED AT HIS 2 WEEK FOLLOW UP APPOINTMENT. SUBJECT WAS STARTED ON DOXYCYCLINE AND INSTRUCTED TO DECREASE HIS ACTIVITY, ICE, ELEVATE AND CONTINUE DOING HIS EXERCISES 3 TIMES A DAY. 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). D10 - MEDICAL PRODUCT: FEMUR CEMENTED CRUCIATE RETAINING (CR) CATALOG # 42502607001 LOT # 66415011. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) CATALOG # 42512100912 LOT # 66561688. ALL-POLY PATELLA CATALOG # 42540200038 LOT # 66635380. PALACOS BONE CEMENT CATALOG # 5051207 LOT # 68991307. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING CELLULITIS AND SWELLING DUE TO INCREASED ACTIVITY TWO WEEKS POST IMPLANTATION AND TREATED WITH ANTIBIOTICS. NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602675 PERSONA CEMENTED TIBIA PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 66588733 00889024632165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other