BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140

    MDR report key: 7288219 · Received February 22, 2018

    Report

    Report Number
    0009613350-2018-00277
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    March 18, 2009
    Report Date
    September 10, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: 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: BONE BREAKAGE. EVENT DESCRIPTION: PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2009 DUE TO LOOSENING OF THE FEMORAL STEM. SURGEON INITIALLY TRIED WITH DUROM WHICH WAS NOT STABLE. THUS DUROM WAS EXCHANGED TO ALLOFIT CUP - REVITAN STEM INTRA OPERATIVELY. DURING IMPLANTATION OF REVITAN STEM, PATIENT'S FEMUR GOT FRACTURED WHICH WAS TREATED INTRA OPERATIVELY WITH CERCLAGE WIRES AND PLATE. REVIEW OF RECEIVED DATA: -SURGICAL REPORT DATED (B)(6) 2009: (BELONGING TO DR. (B)(6) ). PREOPERATIVE DIAGNOSIS: LOOSENING OF THE FEMORAL UNIPOLAR PROSTHESIS OF THE RIGHT HIP SURGEON TRIED IMPLANTING A DUROM SIZE 53 BUT HE WAS NOT SUCCESSFUL. THUS HE DECIDED TO IMPLANT ALLOFIT SIZE 54. WHILE PLACING THE ALLOFIT CUP,SURGEON NOTICED A LITTLE FISSURE AT THE ACETABULAR BONE. THE FISSURE IS NOT DISPLACED AND STABLE. 2 SCREWS WERE PUT. NOTE: NOT ANY STATEMENT ABOUT THE BREAKAGE OF THE FEMUR IS EXPLAINED IN THIS REPORT. -SURGICAL REPORT DATED (B)(6) 2009: (BELONGING TO DR. (B)(6) ) DIAGNOSIS: PERIPROSTHETIC FRACTURE OF THE FEMORAL DIAPHYSIS AND DISTAL FEMUR DURING OPERATION SURGEON STATES THAT DURING THE SURGERY A PERIPROSTHETIC FRACTURE OF THE FEMUR OCCURED. IT WAS A LONG FRACTURE BEGINNING AT LEVEL OF DIAPHYSIS AND EXTENDED UNTIL DISTAL FEMUR. THATS THE REASON WHY DR. (B)(6) WAS ASKED BY DR. (B)(6) FOR HELP DURING THE SURGERY. 3 CABLES FROM SYNTHES WERE USED TO REDUCE THE FRACTURE NICELY AND INSURE AN EXCELLENT CONTACT WITH THE PROSTHESIS. THE FRACTURE IS LONG UNTIL DISTAL PART OF PROSTHESIS. ALSO A PLATE AND SCREWS WERE USED TO FIX. NOTE: THE REASON OF THE FEMUR BREAKAGE OR HOW IT HAPPENED IS NOT EXPLAINED IN THIS REPORT. - IMPLANT STICKERS OF THE NEWLY IMPLANTED PRODUCTS DURING THE REVISION SURGERY ARE RECEIVED. HOWEVER, NO IMPLANT STICKER OF THE PLATE USED ACCORDING TO THE SURGICAL REPORT WAS AVAILABLE. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL PROXIMAL REVITAN COMPONENTS ARE COMPATIBLE WITH ALL DISTAL ONES. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW: - IMPLANT BREAKAGE, BONE FRACTURE DUE TO WRONG PLANNING TEMPLATE USED / MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTER OF ROTATION/LEG LENGTH/OFFSET => POSSIBLE, NO X-RAYS WERE RECEIVED TO CONFIRM THIS RISK, THERFORE CANNOT BE EXCLUDED. - EXCESSIVE LOAD APPLIED TO THE BONE DUE TO EXCESSIVE IMPACTION FORCE APPLIED DURING IMPACTION OF DISTAL FEMORAL STEM => POSSIBLE, OPERATION REPORT DOES NOT EXPLAIN ANYTHING REGARDING HOW THE BREAKAGE OCCURRED, THEREFORE THIS RISK CANNOT BE EXCLUDED. - EXCESSIVE LOAD APPLIED TO THE BONE DUE TO TORSIONAL FORCES GENERATED NOT NEUTRALISED => POSSIBLE, OPERATION REPORT DOES NOT EXPLAIN ANYTHING REGARDING HOW THE BREAKAGE OCCURRED, THEREFORE THIS RISK CANNOT BE EXCLUDED. - EXCESSIVE LOAD APPLIED TO THE BONE DUE TO EXCESSIVE IMPACTION FORCE APPLIED DURING IMPACTION OF ASSEMBLED FEMORAL STEM => POSSIBLE, OPERATION REPORT DOES NOT EXPLAIN ANYTHING REGARDING HOW THE BREAKAGE OCCURRED, THEREFORE THIS RISK CANNOT BE EXCLUDED CONCLUSION: ACCORDING TO THE RECEIVED INFORMATION, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2009 DUE TO THE LOOSENING THE FEMORAL STEM. DURING THE SURGERY, SURGEON INITIALLY TRIED IMPLANTING DUROM, WHICH WAS NOT STABLE. THUS DUROM WAS EXCHANGED TO ALLOFIT CUP - REVITAN STEM INTRA OPERATIVELY. DURING IMPLANTATION OF REVITAN STEM, PATIENT'S FEMUR GOT FRACTURED WHICH WAS TREATED INTRA OPERATIVELY WITH CERCLAGE WIRES AND PLATE. RAW MATERIAL CERTIFICATE OF REVITAN STEM CONFIRMS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE STATEMENT OF THE FEMUR BREAKAGE DOES NOT EXIST IN OP REPORT BY DR. (B)(6), HOWEVER, THIS BREAKAGE IS STATED IN OP REPORT BY DR. (B)(6), WHICH WAS CREATED A MONTH AFTER THE OP DATE. THIS OBSERVATION IS SUSPICIOUS AND IT IS UNKNOWN HOW THE FEMUR BREAKAGE OCCURRED. THEREFORE, IN THE ABSENCE OF NECESSARY INFORMATION IT IS NOT POSSIBLE TO ANALYZE THE EVENT IN DETAIL. HOWEVER, POSSIBLE REASONS OF THE INTRAOPERATIVE BONE FRACTURE INCLUDES EXCESSIVE IMPACTION FORCE APPLIED DURING IMPACTION OF ASSEMBLED FEMORAL STEM, EXCESSIVE IMPACTION FORCE APPLIED DURING IMPACTION OF DISTAL FEMORAL STEM OR WRONG PLANNING TEMPLATE USED / MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTER OF ROTATION/LEG LENGTH/OFFSET. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. 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) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT STAYS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT. DURING IMPLANTATION OF STEM, PATIENT BONE GOT FRACTURED WHICH WAS TREATED INTRA OPERATIVELY WITH CERCLAGE WIRES AND PLATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132069 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140 KWA ZIMMER GMBH N/A 2483688

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R HEAD, ITEM# 193207, LOT# 2491518| INSERT, ITEM# 0100010910, LOT# 2454274| REVITAN, ITEM# 0100402075, LOT# 2476153| SHELL, ITEM# 4266, LOT# 2418097| HEAD, ITEM# 193207, LOT# 2491518| INSERT, ITEM# 0100010910, LOT# 2454274| REVITAN, ITEM# 0100402075, LOT# 2476153| SHELL, ITEM# 4266, LOT# 2418097