BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALLOCLASSIC VARIALL HIP

    MDR report key: 6331398 · Received February 15, 2017

    Report

    Report Number
    0009613350-2017-00259
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    January 18, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS THE INFORMATION FOR THIS CASE COMES FROM A JOURNAL ARTICLE, IT IS NOT SUSPECTED THAT THE DEVICE OR ADDITIONAL INFORMATION IS BEING SUBMITTED FOR REVIEW. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT CURRENTLY AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED TO RECEIVE MORE INFORMATION FOR THIS CASE. TREND ANALYSIS: WAS NOT POSSIBLE TO PERFORM, AS NO ITEM NUMBER WAS AVAILABLE. DEVICE HISTORY RECORDS (DHR): AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING MISSING DEVICE DATA INFORMATION WAS SENT. 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. EVENT SUMMARY: IN THE JOURNAL ARTICLE "LONG-TERM FOLLOW-UP OF PRIMARY TOTAL HIP ARTHROPLASTY WITH THE ALLOCLASSIC VARIALL SYSTEM" IT IS REPORTED THAT THERE WERE FOUR INTRA-OPERATIVE FRACTURES OF THE GREATER TROCHANTER, WHICH WERE SUCCESSFULLY TREATED INTRA-OPERATIVELY WITH CERCLAGE WIRES. 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. REVIEW OF PRODUCT DOCUMENTATION: NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. ROOT CAUSE ANALYSIS: INTRA-OPERATIVE BONE FRACTURE CANNOT BE RELATED TO A SPECIFIC FAILURE MODE. BASED ON THE GIVEN INFORMATION, A ROOT CAUSE ANALYSIS IS THEREFORE NOT POSSIBLE. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE, THE CASE WILL RE-EVALUATED. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE DFMEA. CONCLUSION SUMMARY: THE EVENT IS IMPRECISE AND NEITHER X-RAYS, OPERATIVE NOTES OR OFFICE VISIT NOTES WERE RECEIVED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. THIS EVENT IS MOST PROBABLY RELATED TO THE IMPLANTATION SURGERY OF THE ALLOCLASSIC VARIALL STEM, BUT UNLIKELY RELATED TO THE DEVICE ITSELF. AS THE SURGICAL PROCEDURE WAS NOT SHARED, IT IS UNKNOWN, WHETHER THE SURGEON FOLLOWED THE INSTRUCTIONS FOR IMPLANTATION GIVEN IN SURGICAL TECHNIQUE. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT BETWEEN JANUARY 2001 AND DECEMBER 2002, 273 CONSECUTIVE PRIMARY THAS WERE PERFORMED IN 259 PATIENTS AT A SINGLE CENTRE WITH THE STUDY SYSTEM, USING CERAMIC-ONCERAMIC(81.7 %) OR CERAMIC-ON-HIGHLY-CROSSLINKEDPOLYETHYLENE (18.3 %) ARTICULATIONS. FOUR PATIENTS WERE IMPLANTED WITH ALLOCLASSIC VARIALL HIP IMPLANTS AND EXPERIENCED INTRA-OPERATIVE BONE FRACTURE WHICH WAS TREATED WITH CERCLAGE RINGS. (JOURNAL ARTICLE: LONG-TERM FOLLOW-UP OF PRIMARY TOTAL HIP ARTHROPLASTY WITH THE ALLOCLASSIC VARIALL SYSTEM - JOSEF HOCHREITER, GIOVANNI BRUSAFERRI, KLAUS KIRSCHBICHLER, KATJA EMMANUEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114093 UNKNOWN ALLOCLASSIC VARIALL HIP UNKNOWN KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other