BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD TAPER CERAMIC

    MDR report key: 2251377 · Received September 13, 2011

    Report

    Report Number
    1822565-2011-02080
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Removal / Correction Number
    1822565-08/16/2001-002R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES/X-RAYS FROM THE PRIMARY AND REVISION SURGERIES WERE NOT PROVIDED FOR REVIEW. AT THE TIME OF REVISION, THE DEVICE WAS IN VIVO FOR APPROXIMATELY 11 YEARS AND 10 MONTHS. THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS PREVIOUSLY PART OF FDA REPORTABLE RECALL AS A RESULT OF A SUPPLIER ISSUE. AS THIS DEVICE WAS IMPLANTED PRIOR TO RECALL INITIATION, THE COMPLAINT CAN BE CONSIDERED PREVIOUSLY ADDRESSED. DEVICE HISTORY RECORDS FOR THE PROVIDED LOT NUMBER HAVE BEEN REVIEWED. 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 WAS REVISED DUE TO FRACTURE OF THE CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL HEAD TAPER CERAMIC LZO ZIMMER, INC. 62161200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention