BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 37MM

    MDR report key: 16700847 · Received April 7, 2023

    Report

    Report Number
    0001825034-2023-00755
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    November 30, 2021
    Report Date
    April 5, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304506084
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BMET REGENX PRI TIB TRAY 75MM: CATALOG#141274, LOT#970530; BIOMET FINNED PRI STEM 40MM: CATALOG#141314, LOT#943170; VNGD PS OPEN POR FMRL LT 70: CATALOG#184532, LOT#427700; E1 VNGD PS TIB BRG 71/75X10: CATALOG#EP-183640, LOT#753860. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED SIGN OF BEING IN-VIVO. PEGS WERE NOTED BE FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT PATIENT EXPERIENCED PAIN AND X-RAY FOUND FRACTURED PATELLA PEGS. UPON OPENING, SEVERE METALLOSIS WAS FOUND. A SYNOVECTOMY WAS PERFORMED AND THE PATELLA WAS REPLACED. ALL OTHER COMPONENTS WERE STABLE AND NO DAMAGE WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO A A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF THE DEVICE FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. THE ISSUE HAS BEEN PREVIOUSLY ADDRESSED AND RESOLVED THROUGH OUR CAPA PROCESS. 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 A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SIX (6) YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY OF THE PATELLA COMPONENT AS ALL THREE PEGS ON THE DEVICE FRACTURED OFF. DURING THE REVISION SURGERY, A SIGNIFICANT AMOUNT OF BLACKENED SYNOVITIS DUE TO METALLOSIS WAS NOTED AND A SYNOVECTOMY WAS PERFORMED. THE PATELLA COMPONENT WAS REVISED HOWEVER ALL OTHER COMPONENTS REMAIN IMPLANTED AS NO ISSUES WERE NOTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754507 RGX 3 PEG SER A PATELLA 37MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 141358 416530 00880304506084

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H