BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 2822417 · Received November 2, 2012

    Report

    Report Number
    2648920-2012-00235
    Event Type
    Injury
    Date Received
    November 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE LETTER AND EMAILS INCLUDED SUGGEST THAT THE PT HAS ELEVATED CHROMIUM ION LEVELS AND CORROSION; HOWEVER NO DOCTOR'S NOTES ARE AVAILABLE TO CONFIRM THIS. NO X-RAYS, PHOTOGRAPHS, OP-NOTES, LAB REPORTS OR ANY RECORDS ARE AVAILABLE. IT IS NOT KNOWN IF THE SURGICAL TECHNIQUE WAS FOLLOWED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN AND TROUBLE WHEN STANDING. IT IS REPORTED THAT THE PT'S SURGEON INFORMED HER THAT HER COMPONENTS OF METAL ARE REACTING AND HER CHROMIUM LEVELS ARE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL HEAD LPH ZIMMER 60753137

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT# 60014594| LOT# 60836560| TM FEMORAL STEM: CATALOG # 00786401220,| ZIMMER (B)(4)| THE FOLLOWING WERE MANUFACTURED BY| TM SHELL WITHOUT HOLES: CATALOG# 00620205021,| TRILOGY LONGEVITY POLY LINER: CATALOG# 00630505032| LOT# 60819010