BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED PRECOAT TIBIAL COMPONENT

    MDR report key: 5843400 · Received August 3, 2016

    Report

    Report Number
    0002648920-2016-00973
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    September 17, 2014
    Report Date
    September 15, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2016-00973, 0001822565-2016-02662, 0001822565-2017-06500, 0001822565-2017-06501. CONCOMITANT MEDICAL PRODUCT(S): NEXGEN ALL-POLY PATELLA, 32MM X 8.5MM (PART# 00-5972-065-32, LOT# 62654372); NEXGEN LCCK ARTICULAR SURFACE, 17MM (PART# 00-5994-042-17, LOT# 60848644); NEXGEN LCCK OPTION FEMORAL SIZE G, RIGHT (PART# 00-5994-017-92, LOT# 62255096); NEXGEN PRECOAT STEMMED TIBIAL PLATE, SIZE 6 (PART# 00-5980-047-02, LOT# 62364122); NEXGEN STRAIGHT STEM EXTENSION 24MM X 145MM (100MM) (PART# 00-5988-010-24, LOT# 60922516); DISTAL FEMORAL AUGMENT BLOCK (PART# 00549003620, LOT# 62377580); POSTERIOR FEMORAL AUGMENT BLOCK (PART# 00549003602, LOT# 62332250); POSTERIOR FEMORAL AUGMENT BLOCK (PART# 00549003601, LOT# 62397229). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 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 IS REPORTED THAT THE PATIENT WAS UNDERWENT KNEE ARTHROPLASTY REVISION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494507 NEXGEN STEMMED PRECOAT TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER MANUFACTURING B.V. 62364122

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R