BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET I-BEAM PRIMARY TIBIAL STEM

    MDR report key: 6862000 · Received September 13, 2017

    Report

    Report Number
    0001825034-2017-07022
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    April 10, 2017
    Report Date
    August 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CUSTOM TITANIUM CRUCIATE RETAINING FEMORAL, CAT#: CP113618, LOT#: 170070. BIOMET ILOK PRIMARY TIBIAL TRAY, CAT#: 141215, LOT#: 977050. VANGUARD TIBIAL BEARING, CAT#: EP-183462, LOT#: 480970. BIOMET SERIES-A STANDARD PATELLA, CAT#: 184764, LOT#: 974490. COBALT BONE CEMENT, CAT#: 402283, LOT#: 604040. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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: 0001825034-2017-07020, 0001825034-2017-07021, 0001825034-2017-07078, 0001825034-2017-07079, 0001825034-2017-07080.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OTHER PRODUCTS RETURNED INVOLVED IN EVENT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS LOOSENING, INFECTION AND WEAR OF COMPONENTS. INTRAOPERATIVELY, METALLOSIS WAS NOTED IN THE JOINT AND SCRATCHES ON THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643138 BIOMET I-BEAM PRIMARY TIBIAL STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 974490

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R