BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED KNEE STEM W/STEM 20 MM X 80 MM

    MDR report key: 6561915 · Received May 11, 2017

    Report

    Report Number
    0001825034-2017-03208
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    July 16, 2015
    Report Date
    October 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK121149
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). CONCOMITANT MEDICAL PRODUCTS: AGC PATELLA ARCOM POLY. WITH WIRE 34MM CATALOG 11-150828 LOT 653030; VAN PS OPEN INTL FEM RT 65, CATALOG 183108 LOT 506070, DEPUY SMARTSET BONE CEMENT CATALOG# 545050500 LOT# 2482478, DEPUY SMARTSET BONE CEMENT CATALOG# 545050500 LOT# 2482479, BIOMET STEMMED TIBIAL PLATE CATALOG# 141514 LOT# 161550. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2016-04791-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DEATH WAS REPORTED APPROXIMATELY ONE MONTH POST REVISION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [LOCATION UNKNOWN] TO ZIMMER BIOMET FOR INVESTIGATION. 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 TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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 · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, NICKEL ALLERGY, AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. LEGAL COUNSEL ALSO REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS APPROXIMATELY ONE MONTH POST REVISION.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, NICKEL ALLERGY, LIMITED RANGE OF MOTION AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. LEGAL COUNSEL ALSO REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS APPROXIMATELY ONE MONTH POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342640 BIOMET SPLINED KNEE STEM W/STEM 20 MM X 80 MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 187910

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R