BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX 3 PEG SERIES A PATELLA 37MM

    MDR report key: 8465690 · Received March 29, 2019

    Report

    Report Number
    0001825034-2019-01498
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    January 22, 2019
    Report Date
    October 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K083782
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS RETURNED AND VISUAL EXAMINATION OF THE PRODUCT SHOWED SIGNS OF BEING IMPLANTED, WAS WORN, DISCOLORED, HAD FOREIGN MATERIAL AND TWO OF THE POSTS HAD FRACTURED OFF. THE ROOT CAUSE REMAINS UNCHANGED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE REVISION OPERATIVE RECORD NOTED TWO PEGS OF THE PATELLA WERE FRACTURED AND ONE PEG WAS INTACT AS WELL AS SCAR TISSUE AROUND THE PATELLA REGION WHICH WAS EXCISED. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT A REVISION KNEE ARTHROPLASTY APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO A FRACTURED PATELLA COMPONENT. THE REVISION OPERATIVE REPORT NOTED SCAR TISSUE AROUND THE PATELLA, WHICH WAS EXCISED, AND TWO OF THE PATELLA PEGS HAD FRACTURED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD PS FEMORAL COMPONENT, CATALOG # 184532, LOT # 135400. VANGUARD PS TIBIAL BEARING, CATALOG # EP-183660, LOT # 693700. BIOMET REGENEREX TIBIAL TRAY, CATALOG # 141275, LOT # 061080. BIOMET FINNED PRI STEM, CATALOG # 141314, LOT # 858570. OUR INVESTIGATION IS ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. LOCATION OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND WAS REVISED DUE TO THE PATELLA FRACTURING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256380 REGENEREX 3 PEG SERIES A PATELLA 37MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. NI 170040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.