BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TIBIA 5 SZ G RT- CEMENTED

    MDR report key: 19668378 · Received July 3, 2024

    Report

    Report Number
    3007963827-2024-00253
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    July 26, 2021
    Report Date
    December 18, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024471108
    PMA / PMN Number
    K113369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS (REPORTED): 42500606802, PERSONA FEMORAL SZ 10 RT- CEMENTED, LOT# 63629202; 42521401012, PERSONA ART SURFACE 12MM, LOT# 64535690; 42557000114, PERSONA TIBIAL STEM EXTENSION 14MM +30MM- CEMENTED, LOT# 63693052; 42540000038, ALL POLY PATELLA SZ 38X9.9MM- CEMENTED, LOT# 63689686; 42521401012, PERSONA ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 12MM, LOT# 63379063; THIS EVENT WAS PREVIOUSLY REPORTED UNDER A DIFFERENT MANUFACTURER NUMBER SEE MDR: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. IT WAS REPORTED THAT A PATIENT REQUIRED A TWO-STAGE REVISION DUE TO RECURRENT INFECTION WHICH ALSO CAUSED PAIN, RANGE OF MOTION LOSS, AND BONE LOSS/BREAKDOWN (OSTEOLYSIS). DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. 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 A PATIENT BEGAN TO EXPERIENCE PAIN, WARMTH, EFFUSION, AND DECREASED RANGE OF MOTION ABOUT THREE YEARS TWO MONTHS POST IMPLANTATION AND AN ASPIRATION OF THE SYNOVIAL FLUID WAS COMPLETED. THREE DAYS LATER THE PATIENT UNDERWENT AN I&D, WITH POLY EXCHANGE, FOR A PERIPROSTHETIC INFECTION WITHOUT COMPLICATION. AFTER COMPLETING IV AND ORAL ANTIBIOTICS, THE PATIENT BEGAN TO EXPERIENCE PAIN, SWELLING, LIMITED RANGE OF MOTION, AND DIFFICULTY AMBULATING. EIGHT MONTHS AFTER THE I&D, AN ASPIRATION WAS COMPLETED AND THE CULTURE RESULTS INDICATED AN ONGOING INFECTION RELATED TO STAPH EPIDERMITIS. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION WHERE ALL IMPLANTS WERE REMOVED AND A TEMPORARY SPACER WAS IMPLANTED. APPROXIMATELY TWO MONTHS LATER, THE PATIENT UNDERWENT THE SECOND STAGE REVISION WHERE MODERATE OSTEOLYSIS WAS NOTED AROUND THE TIBIAL AND FEMORAL COMPONENTS THAT WAS CONSISTENT WITH THE PREVIOUS INFECTION/EXPLANTATION AND A REVISION KNEE SYSTEM WAS IMPLANTED WITHOUT COMPLICATION.

    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
    467072 PERSONA TIBIA 5 SZ G RT- CEMENTED PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63621645 00889024471108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R