BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 37MM

    MDR report key: 7943882 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09161
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    September 6, 2018
    Report Date
    May 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK083782
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED DEVICES CONFIRMED THAT THE TIBIAL TRAY HAS FRACTURED IN THE MIDDLE ANTERIOR-POSTERIOR AND THE PATELLA PEGS HAVE SHEARED OFF. THE LOCKING BAR DISASSOCIATING COULD NOT BE CONFIRMED HOWEVER, IT WAS FOUND THAT THE LOCKING BAR HAS FRACTURED AND THE FRACTURE OF THE LOCKING BAR COULD HAVE LED TO THE LOCKING BAR DISASSOCIATING IN VIVO. THE TIBIAL BEARING HAS NUMEROUS BLACK PARTICLES EMBEDDED IN THE ARTICULATING SURFACES AND THE LOCKING BAR CHANNEL WHICH LIKELY CAME FROM THE FRACTURED TIBIAL TRAY, PATELLA, AND LOCKING BAR. ADDITIONALLY, THE WEAR PATTERN ON THE BEARING WOULD INDICATE A BACK AND FORTH MOTION OF THE FEMORAL, LOADING AND UNLOADING THE TIBIAL ON THE MEDIAL SIDE, WHICH IS NOT NOTED ON THE LATERAL SIDE. THE FEMUR SHOWS SIGNS OF SLIGHT DELAMINATION ON THE CONDYLES WHICH COULD HAVE BEEN THE RESULT OF THE METAL DEBRIS EMBEDDED IN THE TIBIAL BEARING ABRADING THE CONDYLE SURFACE FINISH. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE RECORDS FOUND THE FOLLOWING: "MILD DEGENERATIVE CHANGES OF THE LEFT KNEE PRE-ARTHROPLASTY. POST ARTHROPLASTY IMAGES DEMONSTRATE POSSIBLE PATELLAR IMPLANT FRACTURE WITH FRACTURED APPEARANCE OF THE PEGS. POSSIBLE EVIDENCE OF EARLY LOOSENING INVOLVING THE ANTERIOR TIBIAL COMPONENT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED FOR THE TIBIAL TRAY, LOCKING BAR, AND PATELLA FRACTURES. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09163 - 1.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO PAIN AND IMPLANT COMPONENT FRACTURE 2 YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR POR FMRL-LT 62.5 P/N 183066 L/N: 928230. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 09154, 0001825034 - 2018 - 09161, 0001825034 - 2018 - 09163, 0001825034 - 2018 - 09165.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY 2 YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND IMPLANT COMPONENT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783361 RGX 3 PEG SER A PATELLA 37MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 778870

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R