BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH

    MDR report key: 9162740 · Received October 7, 2019

    Report

    Report Number
    0001822565-2019-04312
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 16, 2019
    Report Date
    December 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K181947
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE RETAINER (ITEM: 88-4400-791-00) EXHIBITS MATERIAL TRANSFER FROM THE INNER LID STOCK (ITEM: 88-4400-531-00). DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE PRODUCT WAS LIKELY NON-CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL BASED ON THE EVALUATION OF THE RETURNED PRODUCT. THE WHITE RESIDUE FOUND ON THE RETAINER IS GLUE TRANSFERRED FROM THE TYVEK LID DURING THE SEALING OPERATION DUE TO A SMALL CLEARANCE BETWEEN THE TYVEK LID AND THE RETAINER. THIS ISSUE IS A COMMON PHENOMENON AND DOES NOT CAUSE ANY RISK TO THE PATIENT. ALL MATERIALS ARE BIOCOMPATIBLE AND THE ADHESIVE RESIDUE DOES NOT CONTACT THE IMPLANT BECAUSE IT IS CONTAINED IN A POLY BAG. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO DESIGN DEFICIENCY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 DURING SURGERY, SOME RESIDUE WAS NOTICED ON THE CLEAR INSIDE LID. ANOTHER PRODUCT WAS OPEN AND USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956374 STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64412364

    Patients

    Seq Age Sex Outcome Treatment
    1