BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION, HEAD, XL 36/+7, TAPER 12/14

    MDR report key: 6521964 · Received April 26, 2017

    Report

    Report Number
    0009613350-2017-00548
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    June 28, 2016
    Report Date
    April 26, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PK073567
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    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 (B)(4) 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 WAS NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. TREND ANALYSIS: NO TREND IDENTIFIED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AT ZIMMER GMBH 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 GMBH 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: PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY WITH DUROM COMPONENT AND REPLACED WITH CONTINUUM CUP - BIOLOX HEAD ON (B)(6) 2014. SUBSEQUENTLY, PATIENT HAD RE-REVISION (SECOND REVISION) SURGERY ON (B)(6) 2016, IN WHICH CONTINUUM CUP - BIOLOX HEAD WAS REVISED DUE TO CHRONIC DISLOCATION AND PSEUDO TUMOR. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED TWO DISLOCATIONS ON (B)(6) 2015 & (B)(6) 2016 WHICH WERE TREATED BY CLOSED REDUCTION. REVIEW OF RECEIVED DATA: SEVERAL DOCUMENTS WERE RECEIVED FOR THIS PATIENT. THE OPERATIVE REPORT DATED JUN 05, 2009 DESCRIBES THAT THE PATIENT WAS IMPLANTED WITH DUROM DUE TO LEFT HIP OSTEOARTHRITIS. NO OTHER RELEVANT INFORMATION AVAILABLE. THE OPERATIVE REPORT DATED (B)(6) 2014 DESCRIBES THAT THE DUROM WAS REVISED DUE TO ALVAL. A 58 ZIMMER TRABECULAR METAL CONTINUUM MULTIHOLE CUP, 3 SCREWS, LINER AND CERAMIC HEAD WERE PLACED. THIS FOUND TO BE IN VERY NICE POSITION AND VERY STABLE. THE OPERATIVE REPORT DATED (B)(6) 2016 DESCRIBES THAT PATIENT HAD HIS SECOND REVISION DUE TO CHRONIC DISLOCATION OF THE LEFT HIP. DURING THE SURGERY A VERY LARGE PSEUDOTUMOR WAS DETECTED. FOLLOWING THIS, THERE WAS A LARGE AMOUNT OF HYPERTROPHIC SYNOVIUM. AFTER REMOVING THE COMPONENTS A ZIMMER CONSTRAINED LINER, HEAD WITH A LOCKING RING WERE PLACED. THIS FOUND TO BE IN EXCELLENT POSITION. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. THE LOCATION OF THE PRODUCT IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: DISLOCATION (SHORT-TERM MANIFESTATION OF HARM) DUE TO USER ERROR - JOINT LAXITY => NOT POSSIBLE: THE FIRST DISLOCATION WAS OCCURRED AFTER 1 YEAR OF IMPLANTATION. DISSOCIATION OF COMPONENTS (HEAD/ADAPTER AND/OR ADAPTER/STEM CONNECTION) DUE TO INADEQUATE LOCKING STRENGTH OF HEAD/ADAPTER AND/OR ADAPTER/STEM TAPER JUNCTIONS AND/OR FOR HEADS/CONSTRAINTED LINERS/CUP DUE TO HEAD AND/OR ADAPTER AND/OR LINER/CUP DESIGN (TAPER ANGLES, MATERIAL, SURFACE FINISH, TOLERANCES, ETC.) => POSSIBLE: AS NO X-RAYS WERE PROVIDED IT IS UNKNOWN HOW THE COMPONENTS WERE IMPLANTED. THEREFORE, THIS POINT CANNOT BE EXCLUDED. DISSOCIATION OF COMPONENTS (HEAD/ADAPTER AND/OR ADAPTER/STEM CONNECTION) DUE TO ADAPTER AND/OR HEAD DAMAGED DURING INTRAOPERATIVE ASSEMBLY AND COMPONENTS DO NOT LOCK TOGETHER (SHORT-TERM MANIFESTATION OF HARM) => POSSIBLE: AS NO X-RAYS WERE PROVIDED IT IS UNKNOWN HOW THE COMPONENTS WERE IMPLANTED. THEREFORE, THIS POINT CANNOT BE EXCLUDED. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT RECEIVED A BIOLOX HEAD AFTER A DUROM REVISION ON (B)(6) 2014. AFTER 2 YEARS IN VIVO, THE BIOLOX HEAD WAS REVISED DUE TO CHRONIC DISLOCATIONS. PATIENT EXPERIENCED TWO DISLOCATIONS ON (B)(6) 2015 AND (B)(6), 2016 WHICH WERE TREATED BY CLOSED REDUCTION. THE REVISION WAS DONE ON (B)(6) 2016. DURING THE REVISION SURGERY, A VERY LARGE PSEUDOTUMOR WAS DETECTED. NO DEVICES HAVE BEEN RETURNED TO ZIMMER BIOMET FOR EVALUATION. IN THE RECEIVED DOCUMENTS IT WAS NOTED THAT THERE WAS NO EVIDENCE FOR HARDWARE FRACTURE OR LOOSENING. NO INFORMATION RECEIVED IF THE PATIENT HAD SOME RISKS FOR DISLOCATION. IT IS UNKNOWN HOW THE 2 DISLOCATION WERE OCCURRED. NO SPECIFIC PATIENT INFORMATION SUCH AS ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) WAS PROVIDED. BASED ON THE PROVIDED DOCUMENTS AND PERFORMED INVESTIGATION, A SPECIFIC ROOT CAUSE FOR THE DISLOCATIONS CANNOT BE DONE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR INVESTIGATION. OP REPORTS WERE PROVIDED. 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. 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) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THIS IS A SPLIT COMPLAINT WITH ZIMMER INC. (B)(4) AND WAS REPORTED UNDER CMP-(B)(4). THE PATIENT HAD A PREVIOUS SURGERY WHICH WAS REPORTED UNDER CMP-(B)(4). (B)(4).

    Description of Event or Problem · 1

    A LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX OPTION, HEAD, XL 36/+7, TAPER 12/14 ON THE LEFT SIDE ON (B)(6) 2014. THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO CHRONIC DISLOCATION, A LARGE PSEUDOTUMOR WAS ALSO DISCOVERED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304106 BIOLOX OPTION, HEAD, XL 36/+7, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS JDI ZIMMER GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R