BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA

    MDR report key: 8479147 · Received April 3, 2019

    Report

    Report Number
    0001825034-2019-01257
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    December 13, 2018
    Report Date
    September 30, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    ZFA 2017-15
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, D9, G3, G6, H2, H6, H10. THE COMPLAINT SAMPLE WAS RETURNED AND VISUAL EXAMINATION OF THE PRODUCT EXHIBITED WEAR CONSISTENT WITH USAGE AND ONE OF THE PATELLA PEGS HAD FRACTURED. 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

    COMPLAINT SAMPLE WAS EVALUATED VIA OP-NOTES AND THE REPORTED EVENT WAS CONFIRMED. PRIMARY OPERATIVE NOTES INDICATE NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES PROVIDED STATE THAT DURING SURGERY ONE OF THE PEGS WAS IDENTIFIED AS BROKEN AND LOOSE, WHILE THE OTHER 2 PEGS WERE STILL ATTACHED. SYNOVITIS AND NECROTIC TISSUE WAS ALSO SEEN. THERE WAS SOME CORROSION FROM IMPLANT. X-RAY PRIOR TO REVISION SURGERY INDICATED A FRACTURED PEG. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATELLAR BUTTON FAILURE APPROXIMATELY TWO YEARS POST IMPLANTATION. SUBSEQUENTLY, DURING THAT REVISION PROCEDURE, THE SURGEON NOTED ONE OF THE PEGS WAS BROKEN AND LOOSE WHILE THE OTHER TWO PEGS WERE STILL ATTACHED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: RGX 3 PEG SER A PATELLA; P/N: 141355, L/N: 628500. E1 VNGD PS TIB BRG; P/N: EP-183640, L/N: 403530. BIOMET FINNED PRI STEM; P/N: 141314, L/N: 409010. BMET REGENX PRI TIB TRAY; P/N: 141273, L/N: 740320. VGD PS OPEN POR FEM; P/N: 184506, L/N: 726240. 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. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATELLAR BUTTON FAILURE APPROXIMATELY TWO YEARS POST IMPLANTATION.  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272958 RGX 3 PEG SER A PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 628500

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R