BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGLIANI/FLATOW MODULAR HUMERAL HEAD

    MDR report key: 1954614 · Received December 15, 2010

    Report

    Report Number
    1822565-2010-01367
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    August 12, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM MEDWATCH REPORT #2601050000-2010-8004. EVALUATION SUMMARY: THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICES WERE IMPLANTED IN (B)(6) 2010 AND THAT THE PT WAS REVISED FOR INFECTION IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW MODULAR HUMERAL HEAD SHOULDER PROSTHESIS KWR ZIMMER, INC. 61285403

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ZIMMER TRABECULAR METAL SHOULDER HUMERAL STEM| CATALONG #00111314001, LOT # 69514226| CATALOG #00434811413, LOT # 61232933| PALACOS R & G BONE CEMENT