BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ZIMMER BURCH SCHNEIDER CAGE

    MDR report key: 6371313 · Received March 2, 2017

    Report

    Report Number
    0009613350-2017-00321
    Event Type
    Death
    Date Received
    March 2, 2017
    Report Date
    February 28, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWZ
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHR): AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. REVIEW OF EVENT DESCRIPTION: ACCORDING TO THE INFORMATION RECEIVED IN THIS JOURNAL ARTICLE, THREE PATIENTS HAVE DIED DUE TO UNKNOWN REASONS. THERE IS NO RELATION MADE BETWEEN A POTENTIAL PRODUCT FAILURE AND THE REPORTED DEATHS. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE DETERMINATION USING DFMEA : IMPINGEMENT WITH STEM (DECREASED ROM), DISLOCATION, SUBLUXATION, MIGRATION OF IMPLANT, STRESS SHIELDING DUE TO MALPOSITIONING OF THE IMPLANT, WRONG ALIGNMENT: POSSIBLE: BASED ON THE GIVEN INFORMATION IT CANNOT BE EXCLUDED. CONCLUSION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED IN THIS JOURNAL ARTICLE, THREE PATIENTS HAVE DIED DUE TO UNKNOWN REASONS. HOWEVER, THERE IS NO RELATION MADE BETWEEN A POTENTIAL PRODUCT FAILURE AND THE REPORTED DEATHS NEITHER X-RAYS, OPERATIVE NOTES, NOR OFFICE VISIT NOTES WERE RECEIVED FOR A DEEP ASSESSMENT. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE FOR THE INVESTIGATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THREE PATIENTS WERE IMPLANTED WITH A BURCH SCHNEIDER CAGE (EXACT CATALOGUE NUMBER UNKNOWN) AND DIED ON AN UNKNOWN DATE. HOWEVER, THERE IS NO RELATION MADE BETWEEN A POTENTIAL PRODUCT FAILURE AND THE REPORTED DEATHS. REFERENCE: THE RECONSTRUCTION OF PERIPROSTHETIC PELVIC DISCONTINUITY, B.A ROGERS, THE JOURNAL OF ARTHROPLASTY, 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156839 UNKNOWN ZIMMER BURCH SCHNEIDER CAGE BURCH SCHNEIDER CAGE KWZ ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death