BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH KNEE STEM 12X40

    MDR report key: 6632237 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03818
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    November 26, 2016
    Report Date
    November 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT AGE: PATIENT WAS BORN IN (B)(6). UDI- (B)(4). CONCOMITANT MEDICAL DEVICE(S):- BIOMET SMOOTH KNEE STEM 14X80, ITEM # 145024, LOT # 934030. VANGUARD DA 360 O/S TIBIAL TRAY COCR 67, ITEM # 161429, LOT # 3582208. VANGUARD SSK 360 FEMUR R 67.5, ITEM # 185265, LOT # 3636273. BIOMET 360 OFFSET ADAPTER 2.5MM, ITEM # 185210, LOT # 827040. VANGUARD DA 360 TIBIAL BEARING ARCOM 63/67X18, ITEM # 161443, LOT # 3217590. FOREIGN SOURCE- (B)(4. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00480, 0001825034-2017-03816, 3002806535-2017-00481, 0001825034-2017-03819, 3002806535-2017-00482.

    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ASPIRATION AS WELL AS AN EXAM UNDER ANESTHESIA APPROXIMATELY TEN MONTHS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411690 BIOMET SMOOTH KNEE STEM 12X40 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 378490

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R