BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED KNEE STEM

    MDR report key: 6965083 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09473
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    November 2, 2016
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK121149
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04477. 0001825034-2017-04461. 0001825034-2017-04462. CONCOMITANT PRODUCTS: BMT SPLINED KNEE STM 14X80 CATALOG# 141614 LOT# 408790, BIOMET ILOK STEM TIB TRAY 67MM CATALOG# 141512 LOT# 286860, BMT SPLINED KNEE STM 18X80 CATALOG# 141618 LOT# 680890, VNGD TI FEM SSK 60MM RT CATALOG# CP113122 LOT# 843030, VNGD DIST FEM AUG 60X5 RL/LM CATALOG# 184102 LOT# 235510, BIOMET TIB BLOCK 6MM 67 CATALOG# 141742 LOT# 430780, BIOMET TIB BLOCK 6MM 67 CATALOG# 141742 LOT# 513220, VNGD SSKPSC TIB BRG S 14X63/67 CATALOG# 183824, LOT# 846640. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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 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. 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 PATIENT WAS REVISED DUE TO FEMORAL LOOSENING APPROXIMATELY FIVE YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744927 BIOMET SPLINED KNEE STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 408790

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R