BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 28MM

    MDR report key: 10374904 · Received August 6, 2020

    Report

    Report Number
    0001825034-2020-03092
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    February 2, 2020
    Report Date
    January 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304554405
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    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 NOT CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PATELLA FOUND SIGNS OF BEING IMPLANTED WEAR/DISCOLORATION / FOREIGN MATERIAL AND ALL THREE OF THE POSTS HAVE FRACTURED OFF. THE REMAINING DEVICES WERE NOT RETURNED FOR EVALUATION. WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H2, H3, H6, H10. D11: MEDICAL PRODUCTS: PN: 184520, VNGD PS OPEN POR FMRL LT, LN: 966170 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). ASSOCIATED PRODUCTS : ITEM#: 141205, BIOMET TIBIAL LOCKING BAR, LOT#: 588070 ITEM#: 141314, BIOMET FINNED PRI STEM 40MM, LOT#: 761940. ITEM#: 141271, BMET REGENX PRI TIB TRAY 63MM COCR 63MM, LOT#: 030910. ITEM#: EP-183626, E1 VNGD PS TIB BRG 63/67X16 X 16, LOT#: 984900. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03094, 0001825034-2020-03093, 0001825034-2020-03091, 0001825034-2020-03090.

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY FOUR YEARS AGO. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE SIX MONTHS AGO FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839445 RGX 3 PEG SER A PATELLA 28MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 006170 00880304554405

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10