BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 28MM

    MDR report key: 9962571 · Received April 15, 2020

    Report

    Report Number
    0001825034-2020-01565
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    December 17, 2019
    Report Date
    October 12, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K083782
    Removal / Correction Number
    N/A
    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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SIGNS OF BEING IMPLANTED INCLUDING WEAR, DISCOLORATION, FOREIGN MATERIAL, AND 3 OF THE POSTS HAVE FRACTURED OFF. NO UPDATE TO PREVIOUSLY REPORTED ROOT CAUSE. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: E1 VNGD PS TIB BRG 71/75X10 CATALOG#: EP-183640 LOT#: 357950, BMET REGENX PRI TIB TRAY 75MM CATALOG#: 141274 LOT#: 376360, BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 842180, VNGD PS OPEN POR FMRL LT 65 CATALOG#: 184528 LOT#: 011600. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION OPERATIVE NOTES STATE THAT PATELLA WAS NOTED TO BE BROKEN OFF. ALSO, THERE WAS SIGNIFICANT AMOUNT OF BLACKENED SYNOVIUM FROM METALLOSIS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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 LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO METALLOSIS AND A FRACTURED PATELLA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425367 RGX 3 PEG SER A PATELLA 28MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 232590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10