BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION PROXIMAL

    MDR report key: 827700 · Received October 24, 2006

    Report

    Report Number
    1822565-2006-00253
    Event Type
    Malfunction
    Date Received
    October 24, 2006
    Date of Event
    September 26, 2006
    Report Date
    October 4, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWR
    Removal / Correction Number
    1822565-10/16/06-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUTION SUMMARY: INVESTIGATION BY MFR INDICATES THAT THE DEVICE MAY HAVE BEEN CRACKED AS MANUFACTURED, LEADING TO THE FRACTURE. TRIAL EXHIBITS FRACTURE DAMAGE JUST ABOVE LAST THREAD. FRACTURED PORTION OF DEVICE WAS NOT RETURNED FOR REVIEW, AS IT IS STILL IN-VIVO. DEVICE MEETS SPECIFICATION WHERE MEASURED. SCANNING ELECTRON MICROSCOPE EXAMINATION OF FRACTURE SURFACE SHOWED FOREIGN SUBSTANCE COVERING PART OF FRACTURE SURFACE. HOWEVER, MICRO-MECHANISMS OF FRACTURE WERE OBSERVED ON PART OF FRACTURE SURFACE AND FRACTURE APPEARS TO HAVE OCCURRED BY REPEATED LOADING. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF PROVISIONAL MATERIAL SHOWED FE, CR, NI, AND CU ELEMENTAL PEAKS THAT ARE TYPICAL FOR A 17-4 PH SST. SUBSTANCE ON FRACTURE SURFACE SHOWED C, O,CA, SI, S AND AL PEAKS IN SPECTRUM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2006, AFTER TRIAL REDUCTION AND REMOVAL OF TRIAL, X-RAY REVEALED A PIECE OF THE DISTAL PILOT TRIAL HAD BROKEN OFF IN THE HUMERAL CANAL. SURGEON AND PT ELECTED TO LEAVE THE PIECE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION PROXIMAL SHOULDER INSTRUMENT KWR ZIMMER, INC. NA 60492624

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR