BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALLOCLASSIC VARIALL STEM

    MDR report key: 6331335 · Received February 15, 2017

    Report

    Report Number
    0009613350-2017-00253
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    January 18, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    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. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS ARE MARKETED IN USA (I.E. ALLOCLASSIC SL STEM), AND THEREFORE THIS REPORT WAS FILED. 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. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (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 ONE PATIENT UNDERWENT REVISION FIVE MONTHS POSTOPERATIVE DUE TO STEM SUBSIDENCE. A LARGER STEM WAS IMPLANTED. 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: ROOT CAUSE DETERMINATION USING SAP DFMEA: - MIGRATION OF STEM SHORT AND LONG TERM DUE TO USED RASP DOESN'T CORRESPOND TO THE STEM => POSSIBLE: AS NO DETAILS ON SURGICAL PROCEDURE WERE PROVIDED, WE CAN NOT EXCLUDE A DEVIATION FROM THE SURGICAL TECHNIQUE. THE SIZE OF THE RASP AND STEM USED ARE UNKNOWN, THEREFORE IT IS POSSIBLE, THAT THE RASP SIZE USED DID NOT CORRESPOND TO THE STEM SIZE IMPLANTED. - MIGRATION OF STEM SHORT AND LONG TERM DUE TO WRONG SIZE OF THE STEM DUE TO SURGEON DOES NOT COMPLY TO SURGICAL TECHNIQUE. => POSSIBLE: INSTRUCTIONS FOR IMPLANTATION ARE GIVEN IN THE SURGICAL TECHNIQUE AND IFU OF THE DEVICE. THE SURGEON SHOULD STUDY THE SURGICAL TECHNIQUE PRIOR TO THA SURGERY. DUE TO LACK OF DOCUMENTATION, A DEVIATION FROM THE INSTRUCTIONS GIVEN CAN NOT BE EXCLUDED. - MIGRATION OF STEM SHORT AND LONG TERM DUE TO SURGEON USES THE DEVICE FOR WRONG INDICATIONS => POSSIBLE: INSTRUCTIONS FOR IMPLANTATION ARE GIVEN IN THE SURGICAL TECHNIQUE AND THE IFU OF THE DEVICE. THE SURGEON SHOULD STUDY SURGICAL TECHNIQUE PRIOR TO THA SURGERY. DUE TO LACK OF DOCUMENTATION, USAGE OF THE DEVICE FOR WRONG INDICATIONS CAN NOT BE EXCLUDED. CONCLUSION SUMMARY: THE PROTOCOLS OF THE INDIVIDUAL SURGERIES WERE NOT PROVIDED, THEREFORE WE CAN NOT EXCLUDE DEVIATION FROM THE SURGICAL TECHNIQUE AS RECOMMENDED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. FURTHER, NON-COMPLIANCE WITH THE HEALING PLAN CAN NOT BE EXCLUDED. HOWEVER, WITHOUT PRODUCT, SURGICAL REPORTS AND X-RAYS, 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 GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS CMP-(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-CROSSLINKED POLYETHYLENE (18.3 %) ARTICULATIONS. ONE PATIENT WAS IMPLANTED WITH ALLOCLASSIC VARIALL STEM AND EXCHANGED AFTER FIVE MONTHS TO A LARGER STEM DUE TO STEM SUBSIDENCE. (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
    114007 UNKNOWN ALLOCLASSIC VARIALL STEM UNKNOWN LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R