BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18X150 ASCENT FML POROUS STEM

    MDR report key: 6540511 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-02968
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    July 19, 2018
    Report Date
    November 6, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK011219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ASCENT CLSD BOX PS FMRL; P/N: 178044, L/N: 909580. ASCENT CON BEAR 22X79/83 MACH; P/N: RD179286, L/N: 351800. BIOMET OFFSET TIBIAL TRAY 79MM; P/N: 141485, L/N: 544200. OFFSET TIB TRAY 5.0MM ADAPTOR; P/N: 141491, L/N: 843800. POROUS FINN STEM 89MMX15.5; P/N: CP163816, L/N: 640620. 18X150 ASCENT FML POROUS STEM; P/N: CP111992, L/N: 821130. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05196-3.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT-ASCENT CLSD BOX PS FMRL LG R CATALOG# 178044 LOT# 909580, 18X150 ASCENT FML POROUS STEM CATALOG# CP111992 LOT# 821130, BIOMET OFFSET TIBIAL TRAY 79MM CATALOG# 141485 LOT# 544200, OFFSET TIB TRAY 5.0MM ADAPTOR CATALOG# 141491 LOT# 843800, POROUS FINN STEM 89MMX15.5 CATALOG# CP163816 LOT# 640620. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A REVISION OF THE FEMORAL COMPONENT AND TIBIAL BEARING DUE TO IMPLANT FRACTURE. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME. DEVICE CODE: FRACTURE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02968 AND 1825034-2017-05196.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION RECEIVED FROM SALES REPRESENTATIVE INDICATES THAT THERE IS NO KNOWN IMPLANT FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISASSOCIATION APPROXIMATELY 15 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS INDICATED FOR A BEARING EXCHANGE DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A REVISION OF THE FEMORAL COMPONENT AND TIBIAL BEARING DUE TO IMPLANT FRACTURE. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS INDICATED FOR A REVISION PROCEDURE OF THE BEARING AND FEMORAL COMPONENT DUE TO UNKNOWN REASONS. THE CASE WAS CANCELLED, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322606 18X150 ASCENT FML POROUS STEM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 821130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention