BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX PRECOAT FEMORAL COMPONENT

    MDR report key: 6870605 · Received September 15, 2017

    Report

    Report Number
    0001822565-2017-06500
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    September 17, 2014
    Report Date
    September 15, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK960279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS DETERMINED THAT THE MANUFACTURING DATE WAS INCORRECTLY REPORTED ON MEDWATCH# 3007963827-2016-00055 AND THE EVENT WAS TRANSFERRED TO THIS MEDWATCH. 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 PRODUCTS: 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 WAS REPORTED THAT THE PATIENT WAS UNDERWENT KNEE ARTHROPLASTY REVISION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648869 NEXGEN CR-FLEX PRECOAT FEMORAL COMPONENT KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 62261707

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R