BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOFT-S ALLOCLASSIC SHL 56/KK

    MDR report key: 7188816 · Received January 15, 2018

    Report

    Report Number
    0009613350-2018-00061
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    August 8, 2008
    Report Date
    August 10, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICES OR ADDITIONAL INFORMATION ARE BEING SUBMITTED FOR REVIEW. ZIMMER GMBH WINTERTHUR LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER GMBH NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER GMBH AS MUCH INFORMATION AS THEY ARE WILLING TO SHARE TO PROTECT THE RIGHTS OF THEIR CLIENTS. ALL INFORMATION WHICH HAS BEEN PROVIDED FOR THIS PARTICULAR CASE IS ALREADY COVERED IN THE FINAL REPORT. NEVERTHELESS, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO US, A FOLLOW UP REPORT WILL BE SUBMITTED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2, D11. CORRECTION: B4, G4, G7, H3, H6, H10. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INSTABILITY. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT IN (B)(6) 2008 DURING A THR SURGERY TO TREAT COXARTHROSE, WHILE INSERTING THE TRIAL STEM AND AFTER THE IMPLANTATION OF AN ALLOFIT CUP, IT WAS NOTICED THAT THE ALREADY IMPLANTED CUP WAS UNSTABLE AND IT HAD TO BE EXCHANGED INTRAOPERATIVELY. NO SURGICAL DELAY WAS REPORTED. REVIEW OF RECEIVED DATA: THE CASE WAS REPORTED ORIGINALLY AS A DUROM CUP ISSUE, BUT PRODUCT STICKERS IN MEDICAL RECORDS CORRESPOND TO OTHER NON-DUROM IMPLANTS. THE SURGICAL REPORT IN THE RECEIVED DOCUMENTATION DESCRIBES THAT THE PATIENT HAD COXARTHROSE. AN ALLOFIT CUP WAS IMPLANTED. DURING THE SURGERY THE SURGEON NOTICED THAT THE ALLOFIT CUP WAS UNSTABLE. THE ALLOFIT CUP HAD TO BE EXCHANGED INTRA-OPERATIVELY. NO SURGERY DELAY WAS NOTED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE CORRECT SURGICAL STEPS OF IMPLANTATION OF THE ALLOFIT CUP IS DESCRIBED IN THE SURGICAL TECHNIQUE. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW : - INTRAOPERATIVE COMPLICATIONS DUE TO INCORRECT ASSOCIATED INSTRUMENTS USED => POSSIBLE, AS IT IS NOT KNOWN WHICH INSTRUMENTATION WAS USED DURING THE SURGERY, THIS POINT CANNOT BE EXCLUDED. - INTRAOPERATIVE COMPLICATIONS DUE TO INCORRECT ASSEMBLED COMPONENTS AND/OR INCORRECT ALIGNED ASSEMBLY FORCES => POSSIBLE, IT CAN BE THE CASE THAT THE SURGEON DID NOT FOLLOW THE SURGICAL TECHNIQUE FOR CORRECT IMPLANTATION. THEREFORE THIS POINT CANNOT BE EXCLUDED. - INTRAOPERATIVE COMPLICATIONS DUE TO INCORRECT ASSEMBLED COMPONENTS AND/OR INCORRECT ALIGNED REMOVAL FORCES => POSSIBLE, IT CAN BE THE CASE THAT THE SURGEON DID NOT FOLLOW THE SURGICAL TECHNIQUE FOR CORRECT IMPLANTATION. THEREFORE THIS POINT CANNOT BE EXCLUDED. - INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE INSERTION FORCE, LEADING TO WRONG ALIGNED POLE PLUG => POSSIBLE, A WRONG INSERTION FORCE CANNOT BE EXCLUDED. IT IS UNKNOWN IF THE SURGEON DID FOLLOW THE SURGICAL TECHNIQUE. THEREFORE THIS POINT CANNOT BE EXCLUDED. - DEVICE DAMAGE (SCREW BORE, SCREW HEAD) DUE TO EXCESSIVE INSERTION FORCE => POSSIBLE, IT CAN BE THE CASE THAT THE SURGEON DID NOT FOLLOW THE SURGICAL TECHNIQUE FOR CORRECT IMPLANTATION. THEREFORE THIS POINT CANNOT BE EXCLUDED. - DEVICE DAMAGE (SCREW BORE, BORE PLUG) DUE TO EXCESSIVE INSERTION FORCE => POSSIBLE, IT CAN BE THE CASE THAT THE SURGEON DID NOT FOLLOW THE SURGICAL TECHNIQUE FOR CORRECT IMPLANTATION. THEREFORE THIS POINT CANNOT BE EXCLUDED. CONCLUSION SUMMARY: IT WAS REPORTED THAT IN (B)(6) 2008 DURING A THR SURGERY TO TREAT COXARTHROSE. THE CASE WAS REPORTED ORIGINALLY AS A DUROM CUP ISSUE, BUT PRODUCT STICKERS IN MEDICAL RECORDS CORRESPOND TO OTHER NON-DUROM IMPLANTS. THE SURGICAL REPORT IN THE RECEIVED DOCUMENTATION DESCRIBES THAT THE PATIENT HAD COXARTHROSE. AN ALLOFIT CUP WAS IMPLANTED. DURING THE SURGERY THE SURGEON NOTICED THAT THE ALLOFIT CUP WAS UNSTABLE. THE ALLOFIT CUP HAD TO BE EXCHANGED INTRA-OPERATIVELY. NO SURGERY DELAY WAS NOTED. NEITHER X-RAYS NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. HOWEVER, 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 BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) WINTERTHUR LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2008 A ALLOFT-S ALLOCLASSIC SHL 56/KK WAS IMPLANTED AND IT WAS NOTICED THAT THE IMPLANTED CUP WAS UNSTABLE AND IT HAD TO BE EXCHANGED INTRAOPERATIVELY. NO SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35889 ALLOFT-S ALLOCLASSIC SHL 56/KK N/A KWA ZIMMER GMBH N/A 2406195

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR SEE H10 NARRATIVE