BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 31MM

    MDR report key: 7790310 · Received August 16, 2018

    Report

    Report Number
    0001825034-2018-04777
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    May 14, 2018
    Report Date
    September 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK083782
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BMET REGENX PRI TIB TRAY 71 MM CATALOG#: 141273 LOT#: 504530, BIOMET FINNED PRI STEM 40 MM CATALOG#: 141314 LOT#: 063050, VANGUARD CR POR FEM-RT 60 CATALOG#: 183044 LOT#: 860710, E1 VNGD AS TIB BRG 10X71 CATALOG#: EP-189060 LOT#: 663740. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED FROM VISUAL PHOTOGRAPHS PROVIDED. DEVICE WAS NOT RETURNED BACK FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPHS FOR THE EXPLANTED PATELLA IMPLANT PROVIDED SHOWS ALL THREE PATELLA PEGS IS FRACTURED FROM THE DEVICE. THERE IS BONE GROWTH SEEN ON THE DEVICE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE WAS DETERMINED TO BE A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF REGENEREX PATELLA FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FRACTURE OF THE PEGS OF THE PATELLA IMPLANT. THE JOINT SPACE WAS NOTED TO HAVE METALLOSIS AND DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633060 RGX 3 PEG SER A PATELLA 31MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 117460

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R