BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 34MM

    MDR report key: 9511299 · Received December 23, 2019

    Report

    Report Number
    0001825034-2019-05695
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    August 27, 2019
    Report Date
    October 14, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    UDI-DI
    0088030454429
    PMA / PMN Number
    K171054
    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. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SIGNS OF BEING IMPLANTED WEAR/DISCOLORATION / FOREIGN MATERIAL. 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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. PRIMARY OPERATIVE NOTES DOES NOT SUGGEST ANY INTRA OPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES STATE THAT PATELLA HAD ALL THE THREE PEGS HAD BROKEN OFF. SYNOVECTOMY WAS PERFORMED AND DEBRIS WERE IRRIGATED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ISSUE OF RISK OF FRACTURE. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANTS MEDICAL PRODUCTS: RGX 3 PEG SER A PATELLA 34MM; P/N: 141357, L/N: 952030. VNGD PS OPEN POR FMRL LT 75; P/N: 184534, L/N: 763350. E1 VNGD PS TIB BRG 79/83X10 X 10; P/N: EP-183660, L/N: 810930. BMET REGENX PRI TIB TRAY 83MM COCR 83MM; P/N: 141276, L/N: 728280. BIOMET FINNED PRI STEM 40MM; P/N: 141314, L/N: 976290. 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 PATIENT WAS REVISED APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO A SCARRED PATELLA. THE 3 PEGS BROKE OFF AND REMAINED INSIDE THE BONE. A SYNOVECTOMY WAS PERFORMED AND IRRIGATION TO REMOVE ANY METAL DEBRIS. THE PATELLA WAS RESURFACED; 9MM WAS REMOVED OFF PATELLA AND IMPLANTED WITH A 3 PEG 34MM PATELLA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303818 RGX 3 PEG SER A PATELLA 34MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 952030 0088030454429

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R