BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED KNEE STEM 14X80

    MDR report key: 6789893 · Received August 11, 2017

    Report

    Report Number
    0001825034-2017-06296
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    June 27, 2017
    Report Date
    November 9, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL: EXP DATE, PT CODE. 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

    (B)(6). CONCOMITANT: MEDICAL PRODUCTS- VANGUARD SSKPSC TIBIAL BEARING S 12X63/67, CATALOG # 183822, LOT # 936900; VANGUARD DISTAL FEMORAL AUGMENT 60X5 RL/LM, CATALOG # 184102, LOT # 220050; VANGUARD SSK PSC INTERLOK FEMORAL 60 LT, CATALOG # 183322, LOT # 907980; VANGUARD DISTAL FEMORAL AUGMENT 60X5 LL/RM CATALOG # 184122, LOT # 816540; BIOMET SPLINED KNEE STEM 80X12MM, CATALOG # 141612, LOT # 167940; BIOMET OFFSET TIBIAL TRAY 67MM, CATALOG # 141482, LOT # 758790; BIOMET OFFSET TIBIAL TRAY ADAPTOR 5MM, CATALOG # 141491, LOT # 693900; BIOMET SERIES A PATELLA W/WR THN 28 1 PEG, CATALOG # 184722, LOT # 703820. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL RETAINING DEVICE.THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05037-1, 0001825034-2017-06297, 0001825034-2017-06298, 0001825034-2017-06299.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING AN INITIAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567675 BIOMET SPLINED KNEE STEM 14X80 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 555860 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R