BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LEGACY PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE

    MDR report key: 6045571 · Received October 20, 2016

    Report

    Report Number
    0002648920-2016-03217
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 28, 2016
    Report Date
    June 13, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MBH
    PMA / PMN Number
    PK042271
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT CATALOG# 00599601451, LOT# 63261437, TIBIAL COMPONENT STEMMED PRECOAT USE OF THIS TIBIAL COMPONENT WITH LEGACY KNEE - CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULATING SURFACES REQUIRES USING CATALOG# 00598003701, LOT# 63171975, ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52 SUFFIX FEMORALS SIZE CD 12 MM HEIGHT CATALOG# 00596203012, LOT# 62976399. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED ARTICULAR SURFACE FOUND THE DOVETAIL FEATURE WAS FLARED OUT; ONE SIDE IS COMPRESSED. SOME SCRATCHES AND GOUGES WERE FOUND ON THE PART. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IT IS CONSIDERED THAT THE ISSUE WAS NOT CAUSED BY THE MATING TIBIAL COMPONENT AS THERE WAS NO REPORT OF IT HAVING TO BE REPLACED DURING SURGERY. THE DAMAGE OF THE DOVETAIL OBSERVED ON THE RETURNED ARTICULAR SURFACE INDICATES THAT IT WAS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. IT IS LIKELY THAT THE PROBLEM ENCOUNTERED IS RELATED TO SURGICAL TECHNIQUE. 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 WAS REPORTED THAT THE ARTICULAR SURFACE COULD NOT BE COMPLETELY INSERTED IN THE PLATFORM PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696643 NEXGEN LEGACY PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE KNEE, PROSTHESIS MBH ZIMMER MANUFACTURING B.V. N/A 62976399

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR