BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEXGEN TIBIAL TRAY

    MDR report key: 9400888 · Received December 3, 2019

    Report

    Report Number
    0001822565-2019-04902
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    March 12, 2019
    Report Date
    November 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT/ PROVIDED PICTURES SHOWS THAT THE DISTAL SURFACE TO EXHIBIT DAMAGE (NICKED GOUGED) AND THE DOVE TAIL FEATURES TO BE COMPRESSED AND FLARED OUT. DAMAGE TO THE DOVETAIL FEATURE CONFIRMS THE IMPLANT WOULD NOT BE ABLE TO SEAT. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. DAMAGE TO THE ARTICULAR SURFACE CAN OCCUR IF THE ARTICULAR SURFACE IS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. DETAILED INSTRUCTIONS FOR INSERTING THE ARTICULAR SURFACE ARE PROVIDED IN LPS-FLEX FIXED BEARING KNEE SURGICAL TECHNIQUE (97-5964-102-00-REV0616) PG. 15-17. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: ARTICULAR SURFACE SIZE CD 12 MM HEIGHT "USE WITH PLATE 1. ITEM# 00596402212 LOT# 63631104. THE REPORTED EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 ARTICULAR SURFACE WOULD NOT LOCK ONTO THE TIBIAL PLATE. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201760 UNKNOWN NEXGEN TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR