BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGX 3 PEG SER A PATELLA

    MDR report key: 8749815 · Received July 1, 2019

    Report

    Report Number
    0001825034-2019-02848
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Report Date
    October 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    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 IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, AND H10. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: - VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SIGNS OF BEING IMPLANTED WEAR/DISCOLORATION / FOREIGN MATERIAL AND ALL THREE OF THE POSTS HAVE FRACTURED OFF. - THE ROOT CAUSE OF THE EVENT 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.

    Additional Manufacturer Narrative · 0

    EXPLANT DATE: UNKNOWN. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. REVIEW OF RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL IDENTIFIED THE FOLLOWING: IMAGING FINDINGS WHICH RAISE SUSPICION FOR PERIPROSTHETIC LUCENCIES BETWEEN THE PATELLAR HARDWARE AND THE ADJACENT BONE. THIS IS SUSPECTED BE PRESENT, BUT IS DIFFICULT TO CONFIRM WITH THIS SINGLE PROVIDED SUBOPTIMAL LATERAL VIEW. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 WAS CONSIDERED REVISION THREE YEARS POST-IMPLANTATION DUE TO WEAR AND HARDWARE FAILURE OF THE PATELLA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: E1 VNGD PS+ TIB BRG; P/N: EP-183746, L/N: 238830; BMET REGENX PRI TIB TRAY; P/N: 141273, L/N: 185950; RGX 3 PEG SER A PATELLA; P/N: 141356, L/N: 243150; VGD PS OPEN POR FEM; P/N: 184504, L/N: 315870; BIOMET FINNED PRI STEM; P/N: 141316, L/N: 543580. 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 WAS REVISED 3 YEARS POST-IMPLANTATION DUE TO WEAR AND HARDWARE FAILURE OF THE PATELLA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544767 RGX 3 PEG SER A PATELLA PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 243150

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R