BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 34MM

    MDR report key: 8004797 · Received October 25, 2018

    Report

    Report Number
    0001825034-2018-09917
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    April 4, 2017
    Report Date
    July 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE REVISION OPERATIVE NOTES. REVISION OPERATIVE NOTES PROVIDED STATE THAT PATELLA PEGS WERE FRACTURED AND PATELLA CAME OFF EASILY AND THE PEGS WERE SEPARATED FROM THE UNDERLYING BODY OF THE PATELLA. THERE WAS EXTENSIVE SYNOVITIS AND SCARRING. 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 · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN. WHEN THE SURGEON ATTEMPTED TO EXTRACT THE PATELLA, THE PEGS SHEARED OFF AND REMAINED IN THE PATELLA. SURGEON WAS ABLE TO REMOVE THE PEGS FROM THE PATIENT'S PATELLA. EXTENSIVE SYNOVITIS, SCARRING AND CALCIFICATION OF SCAR TISSUE WITH IN THE LATERAL GUTTER WAS REMOVED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: TOBRAYMYCIN BONE CEMENT CATALOG#: 6197-9-010 LOT#: NI, BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 508570, BMET REGENX PRI TIB TRAY 75MM CATALOG#: 141274 LOT#: 461090, E1 VNGD CRL TIB BRG 71/75X10 CATALOG#: EP-183540 LOT#: 207680, VANGUARD CR POR FMRL-LT 72.5 CATALOG#: 183073 LOT#: 087860. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN. WHEN THE SURGEON ATTEMPTED TO EXTRACT THE PATELLA, THE PEGS SHEARED OFF AND REMAINED IN THE PATELLA. SURGEON WAS ABLE TO REMOVE THE PEGS FROM THE PATIENT'S PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848030 RGX 3 PEG SER A PATELLA 34MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 000220

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R