BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGLIANT/FLATOW THE COMPLETE SHOULDER SOLUTION MODULAR HUMERAL STEM

    MDR report key: 1241506 · Received November 20, 2008

    Report

    Report Number
    1822565-2008-00816
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE REVISION SURGERY WAS PERFORMED AFTER THE REPORTED FAILURE OF THE PATIENT'S ROTATOR CUFF. THE REASON FOR REVISION WAS NOT DUE TO IMPLANT FAILURE. NO DEVICE S AND/OR X-RAY WERE RETURNED FOR EVALUATION. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE FOR ITEM. 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. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES FOR ITEMS. 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT PRESENTED WITH FAILED ROTATOR CUFF IN 2008. PATIENT WAS REVISED TO A REVERSE SHOULDER PROSTHESIS. IMPLANT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANT/FLATOW THE COMPLETE SHOULDER SOLUTION MODULAR HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R OFFSET MODULAR HUMERAL HEAD: CATALOG#| BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION| 00430204615| BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION| GLENOID COMPONENT PEGGED: CATALOG#| 00430204046