BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PATELLA COMPONENTS

    MDR report key: 6798890 · Received August 16, 2017

    Report

    Report Number
    0001825034-2017-05994
    Event Type
    Injury
    Date Received
    August 16, 2017
    Report Date
    February 20, 2018
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: BIOMET REGENEREX TIBIAL TRAY 71MM CATALOG 141273 LOT 970500; BIOMET FINNED PRIMARY STEM 40MM CATALOG 141314 LOT 671050; VANGUARD CR FEMUR RIGHT 65MM, CATALOG 183048 LOT 526470; E1 TIBIAL BEARING 12X71 CATALOG EP-189062 LOT 573440. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PATELLA FOUND THE PATELLA PEGS HAVE FRACTURED OFF AND WEAR ON THE PATELLOFEMORAL ARTICULAR SURFACE. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED PATELLA AND NOTED THAT THE DIMENSIONS ARE NOT TO THE PRINT SPECIFICATIONS DUE TO THE FRACTURE. X-RAYS PROVIDED WERE SENT TO HCP FOR REVIEW. THEIR REVIEW NOTED THE PEG USED TO IMPLANT THE PATELLAR COMPONENT HAS BEEN FRAGMENTED. THE LATERAL PORTION APPEARS DETACHED FROM THE REMAINDER OF THE HARDWARE AND SLIGHTLY DISPLACED LATERALLY AND SUPERIORLY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PREVIOUS INVESTIGATION DETERMINED THAT THE MOST PROBABLE ROOT CAUSE FOR THIS TYPE OF EVENT IS THAT 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 THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO THE PATELLA PEGS SHEARING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579483 REGENEREX PATELLA COMPONENTS PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 166810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R