BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PATELLA COMPONENTS - RGX 3 PEG SER A PATELLA 34MM

    MDR report key: 6578784 · Received May 19, 2017

    Report

    Report Number
    0001825034-2017-03380
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 10, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: E1 VANGUARD TIBIAL BEARING, CATALOG EP-189120, LOT 802890; VANGUARD LEFT FEMUR 75MM, CATALOG 183074, LOT 157830; BIOMET REGENEREX TIBIAL TRAY, CATALOG 141276, LOT 572640; MODULAR SPLINED STEM 40MM, CATALOG 141369, LOT 501970; CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 1825034-2017-03381.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PATELLA SHOWED THAT THE PATELLA PEGS ARE FRACTURED AND THE SURFACE IS SHEARED OFF. THE BEARING ALSO HAD METAL FLAKES FROM THE REGENEREX BACKING ON THE PATELLA, THUS CONFIRMING THE COMPLAINT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE WAS DETERMINED TO BE A PREVIOUSLY ADDRESSED LABELING AND TRAINING DEFICIENCY. 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 THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO WEAR AND COMPONENT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360158 REGENEREX PATELLA COMPONENTS - RGX 3 PEG SER A PATELLA 34MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 344270

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R