BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE SIZE EF 14 MM HEIGHT "USE WITH PLATE 5

    MDR report key: 10133844 · Received June 9, 2020

    Report

    Report Number
    0001822565-2020-02009
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 17, 2020
    Report Date
    June 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024211964
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND SIGNS OF USE (NICKED OR GOUGED) AND THE DOVETAIL FEATURE IS FLARED AND COMPRESSED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. 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). CONCOMITANT MEDICAL PRODUCTS: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT, ITEM#: 00599601552, LOT#: 64432266. STEMMED TIBIAL COMPONENT PRECOAT SIZE 5, ITEM#: 00598004701, LOT#: 64368539. REPORT SOURCE - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT SEAT WITH THE TIBIAL TRAY. REPEATED ATTEMPTS WERE UNSUCCESSFUL DURING THE OPERATION. AFTER REPLACEMENT OF THE SAME PRODUCT, IT WAS SUCCESSFULLY IMPLANTED, AND THE OPERATION WAS DELAYED FOR THIRTY MINUTES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597280 ARTICULAR SURFACE SIZE EF 14 MM HEIGHT "USE WITH PLATE 5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 63706803 00889024211964

    Patients

    Seq Age Sex Outcome Treatment
    1