BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR PROLONG ARTICULAR SURFACE

    MDR report key: 6544084 · Received May 4, 2017

    Report

    Report Number
    0001822565-2017-03026
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Report Date
    December 2, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK003910
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED COMPONENT FOUND INFERIOR SIDE OF THE DEVICE EXHIBITS DAMAGE AND DEFORM WHILE THE SUPERIOR SIDE IS GOUGED. DOVETAIL FEATURE IS BOTH COMPRESSED AND FLARED OUT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO USER ERROR. PER THE PACKAGE INSERT (87-6203-453-23 REV. B) SAYS "DO NOT REINSERT AN ARTICULAR SURFACE IMPLANT THAT HAS BEEN INSERTED PREVIOUSLY." DETAILED INSTRUCTIONS FOR INSERTING THE ARTICULAR SURFACE ARE PROVIDED IN THE NEXGEN CR-FLEX FIXED BEARING SURGICAL TECHNIQUE (97-5952-02, REV. 1, PAGE 15) AND THE SURGICAL TIP: ARTICULAR SURFACE INSERTER ¿PROPER TECHNIQUE &USE¿ GUIDANCE DOCUMENT. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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 DEVICE WOULD NOT INSERT AND DID NOT FIT DURING A KNEE ARTHROPLASTY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326980 NEXGEN CR PROLONG ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER, INC. 63548908

    Patients

    Seq Age Sex Outcome Treatment
    1