BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140

    MDR report key: 7755540 · Received August 7, 2018

    Report

    Report Number
    0009613350-2018-00729
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    November 29, 2017
    Report Date
    December 20, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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: STEM BREAKAGE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A REVITAN STEM SYSTEM IN (B)(6) 2010 DURING A REVISION SURGERY FOR A PERIPROSTHETIC FRACTURE. AROUND 7 YEARS POST IMPLANTATION, PATIENT EXPERIENCED A SPONTANEOUS FRACTURE OF THE FEMORAL PROSTHESIS, SUBSEQUENTLY THE PATIENT WAS REVISED 6 MONTHS LATER. REVIEW OF RECEIVED DATA: 12 X-RAYS WERE RECEIVED FROM TIME PERIOD 21.09.2009 TILL 04.05.2018. (X-RAYS OF (B)(6) 2009 WERE NOT EVALUATED, AS THEY ARE NOT RELATED TO THE REPORTED EVENT). X-RAYS EVALUATION PERFORMED BY HEALTHCARE PROFESSIONAL: (B)(6) 2010 PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-PROJECTION: PERIPROSTHETIC FRACTURE B2, INSERTED SHORT STEM PROSTHESIS (FRACTURE LOCATED DISTAL TO THE GREATER TROCHANTER, REACHING THE TIP OF THE PROSTHESIS). (B)(6) 2010: PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-PROJECTION (IN THE OPERATING ROOM): SITUATION AFTER OSTEOTOMY AND FENESTRATION. NEATLY FITTING REVITAN STEM. THREE WIRE CERCLAGE PROXIMALLY IN THE REGION OF THE PROXIMAL STEM PORTION AND TWO WIRE CERCLAGE DISTAL. PARTIALLY OSSEOUS SUBSTANCE LOSS AT THE LEVEL OF THE CONNECTION POINT BETWEEN THE PROXIMAL AND DISTAL STEM ON THE LATERAL SIDE AND IN THE AREA OF THE DISTAL STEM PART PROXIMALLY, BELOW THE CONNECTION POINT AND LATERALLY IN THE MIDDLE OF THE STEM DISTAL. CUP INCLINATION ANGEL APPROX. 55 DEGREES. (B)(6) 2011: PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-PROJECTION: THE BONY STRUCTURES IN THE STEM AREA APPEAR CONSOLIDATED ON THE PELVIS OVERVIEW, THE LAUENSTEIN PROJECTION IS NOT CONCLUSIVELY ASSESSABLE IN THIS VIEW DUE TO THE LACK OF IMAGE QUALITY (PAPER PRINT). COMPARABLE TO THE PRELIMINARY X-RAY FROM 13.08.2010, INCREASE OF THE CUP INCLINATION ANGLE FROM APPROX. 55 DEGREES TO APPROX. 60 DEGREES. IN THE AREA OF THE PROXIMAL TWO THIRD OF THE STEM THERE IS NO DISCERNIBLE POSITIVE FORM-FIT BETWEEN THE PROSTHESIS STEM AND THE PERIPHERAL BONE STRUCTURES. UNCHANGED WIRE CERCLAGES. IMPLANT COMPONENTS WITHOUT EVIDENCE OF MATERIAL FAILURE. (B)(6) 2017: PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-PROJECTION: COMPARED TO THE PREVIOUS X-RAY OF (B)(6) 2001 THE BONY STRUCTURES IN THE LAUENSTEIN RECORDING ARE MORE TRANSPARENT AND CAN BE JUDGED SUFFICIENTLY. THE BONY STRUCTURES IN THE AREA OF THE REVITAN STEM APPEAR CONSOLIDATED WITH PARTIAL BROADENING OF THE CORTICALIS AS AN INDICATION OF THE PERIOSTALE BONE REGENERATION. BREAKAGE OF THE PROSTHESIS AT THE LEVEL OF THE CONNECTION POINT, PROXIMAL STEM PORTION TILTED ABOUT 16 DEGREES MEDIALLY. MISSING BONY FIT BETWEEN DISTAL STEM AND SURROUNDING BONE. IN THE LAUENSTEIN PROJECTION, A WIRE CERCLAGE APPEARS BROKEN IN THE REGION OF THE TROCHANTER WITH A SLIGHTLY DIFFERENT FEMORAL ROTATION COMPARED TO THE PREVIOUS X-RAY. (B)(6) 2018 PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-PROJECTION: COMPARABLE TO THE PREVIOUS X-RAY OF (B)(6) 2017 UNCHANGED CUP INCLINATION ANGLE, THE PROXIMAL STEM PORTION IS TILTED A LITTLE FURTHER TO THE MEDIAL. OTHERWISE, NO SIGNIFICANT CHANGES TO THE PREVIOUS X-RAYS. SURGICAL REPORTS: (B)(6) 2010 SURGERY REPORT (B)(6): INDICATION: DUE TO SINTERED STEM WITH SHORTENED LEG LENGTH OF 2 CM WITH PAINFUL RESTRICTION OF MOVEMENT 3 MONTHS AFTER STEM CHANGE, PLANNED STEM CHANGE WITH RECOVERY OF LEG LENGTH. DIAGNOSIS: STATUS AFTER STEM CHANGE ON (B)(6) 2010 DUE TO PERIPROSTHETIC FRACTURE LEFT, PRIMARY THP LEFT DUE TO COXARTHROSIS ON (B)(6) 2010. TECHNICAL PROCEDURE: REMOVAL OF WIRE CERCLAGES, RE-OSTEOTOMY. AFTER ADMISSION OF THE REVITAN SIZE 140/55/20 WITH RESULTING, DESIRED LEG EXTENSION BY APPROX. 2 CM OSTEOTOMY OF THE MEDIAL CORTICALIS TO APPROACH THE STEM. AFTER REDUCTION FIXATION OF THE TROCHANTER FRAGMENT WITH TWO DOUBLE CERCLAGES AND A SIMPLE CERCLAGE THROUGH THE HOLE OF THE REVITAN STEM. LEAVE THE CERCLAGE IN THE ISTHMUS AREA FOR SECURING. (B)(6) 2018 SURGERY REPORT (B)(6): INDICATION: IMPLANT FAILURE WITH BREAKAGE OF THE REVITAN STEM. TECHNICAL PROCEDURE: AFTER ENTERING THE JOINT NOTED SEROUS SYNOVIAL FLUID AND METALLOSIS. THE REMOVAL OF THE DISTAL STEM PORTION SUCCEEDS BY KNOCKING OUT EPEATEDLY ONLY AFTER ATTACHMENT OF RELIEF HOLES IN THE BOTTOM 2 CM OF THE REVITAN STEM. EXTENSIVE DEBRIDEMENT ACETABULAR AND IN THE AREA OF THE FEMUR TO REMOVE THE METALLOSIS. SUMMARY OF X-RAYS AND SURGICAL REPORTS REVIEW: ON (B)(6) 2010 IMPLANTATION OF A REVITAN STEM LEFT TO RESTORE THE LEG LENGTH AFTER SINTERING OF A STEM WITH LEG SHORTENING BY 2 CM WITH PAINFUL MOVEMENT RESTRICTION THREE MONTHS AFTER STEM CHANGE ON (B)(6) 2010 DUE TO PERIPROSTHETIC FRACTURE LEFT TO HIP TEP LEFT IN COXARTHROSIS ON (B)(6) 2010. INTRAOPERATIVELY REMOVAL OF WIRE CERCLAGES DURING IMPLANTATION OF THE REVITAN STEM. A PREOPERATIVE X-RAY AFTER STEM CHANGE ON (B)(6) 2010 WITH DETECTABLE WIRE CERCLAGES IS NOT AVAILABLE. THE POSTOPERATIVE X-RAY OF (B)(6) 2010 SHOWS THE BONY LOSS OF SUBSTANCE AFTER OSTEOTOMY IN THE REGION OF THE DISTAL STEM PORTION WITH DISTALLY FIXED REVITAN STEM AND A CUP INCLINATION ANGLE OF APPROX. 55 DEGREES. 1 YEAR LATER ON (B)(6) 2011 RADIOLOGICALLY RECOGNIZABLE INCREASE OF THE CUP INCLINATION ANGLE TO APPROX. 60 DEGREES. NO RECOGNIZABLE FORM FIT AT THE INTERFACE BETWEEN TWO THIRDS OF THE STEM AND ADJACENT BONE WITH FIXATION OF THE DISTAL REVITAN STEM DISTALLY WITH EACH PROXIMAL AND DISTAL TWO WIRE CERCLAGES WITHOUT EVIDENCE OF MATERIAL FAILURE. 6 YEARS LATER ON (B)(6) 2017 RADIOLOGICALLY UNCHANGED CUP INCLINATION ANGLE, CONSOLIDATED BONE STRUCTURES IN THE AREA OF THE DISTAL STEM PORTION, BREAKAGE OF THE PROSTHESIS AT THE LEVEL OF THE CONNECTION SITE WITH MEDIAL TILTING OF THE PROXIMAL STEM PORTION BY APPROX. 16 DEGREES, MISSING BONY FIT BELOW THE CONNECTION POINT IN THE AREA OF THE DISTAL PROSTHESIS STEM WHEN DISTALLY FIXED BELOW THE DISTAL CERCLAGE WITH A DETECTABLE FRACTURE OF A PROXIMAL CERCLAGE. 6 MONTHS LATER ON (B)(6) 2018 RADIOLOGICALLY RECOGNIZABLE SITUATION WITH BREAKAGE OF THE REVITAN STEM IN THE AREA OF THE CONNECTION POINT WITH A SLIGHT INCREASE IN MEDIAL TILTING OF THE PROXIMAL STEM PORTION WITH UNCHANGED DISTAL FIXATION OF THE DISTAL STEM PORTION AND UNCHANGED CUP INCLINATION ANGLE. 3 WEEKS LATER ON (B)(6) 2018 PERFORMED REVISION SURGERY OF THE LEFT HIP WITH DESCRIBED EXTENSIVE DEBRIDEMENT ACETABULAR AND IN THE AREA OF THE FEMUR TO CLEAN INTRAARTICULAR METALLOSIS AFTER FIRST REPEATED KNOCKING OUT ATTEMPTS TO REMOVE THE DISTAL STEM PORTION BY ATTACHING RELIEF HOLES IN THE LAST TWO CENTIMETERS DISTAL. A SWISSMEDIC USER REPORT IN GERMAN WAS RECEIVED. DATE OF EVENT: (B)(6) 2017 EVENT DESCRIPTION: IMPLANT FAILURE, FRACTURE OF THE FEMORAL PROSTHESIS IN (B)(6) 2017, IMPLANTED IN (B)(6) 2010 DURING EXCHANGE OF STEM DUE TO SINTERING. THAT STEM WAS IMPLANTED IN (B)(6) 2010 DUE TO PERIPROSTHETIC FERMUR FRACTURE; INITIAL SURGERY PERFORMED IN (B)(6) 2010 DUE TO COXARTHROSIS. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; ACCORDING TO THE INFORMATION RECEIVED THE DEVICE LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: ALL PROXIMAL REVITAN COMPONENTS ARE COMPATIBLE WITH ALL DISTAL ONES ACCORDING TO SURGICAL TECHNIQUE RAW MATERIAL CERTIFICATE OF THE REVITAN STEM HAS BEEN REVIEWED AND CONFIRMED TO CONFORM TO THE SPECIFICATIONS. CONCLUSION SUMMARY: THE POSTOPERATIVE X-RAY ON THE DAY OF THE IMPLANTATION ON (B)(6) 2010 SHOWS AN OPERATION-RELATED, BONY LOSS OF SUBSTANCE IN THE REGION OF THE DISTAL STEM PORTION AT DISTAL FIXATION AND RELATIVELY STEEP CUP INCLINATION ANGLE WITH APPROX. 55 DEGREES. 1 YEAR LATER ON (B)(6) 2011 RADIOLOGICAL EVIDENCE FOR A LACK OF OSTEOINTEGRATION OVER A LONG DISTANCE OF REVITAN STEM WITH UNCHANGED DISTAL FIXATION AND LOW INCREASING INCLINATION OF THE CUP TO APPROX. 60 DEGREES. 6 YEARS AND 6.5 YEARS LATER ON (B)(6) 2017 AND (B)(6) 2018 RADIOLOGICALLY RECOGNIZABLE BREAKAGE OF THE REVITAN STEM WITH MEDIAL TILTING IN RADIOLOGICAL EVIDENCE OF AN UNCHANGED LACK OF OSTEOINTEGRATION OF THE DISTAL PART OF THE REVITAN STEM AND A DISTAL FIXATION OF THE DISTAL PART. THE METALLOSIS DESCRIBED IN THE REVISION REPORT OF(B)(6) 2018 INDICATES AN IMPLANT-RELATED PROLONGED PROCESS WITH METAL WEAR, MOSTLY PROBABLY DUE TO THE BREAKAGE OF THE REVITAN STEM, WHICH HAS ALREADY OCCURRED SOME TIME AGO. THE RADIOLOGICAL FINDING OF A DISTAL FIXATION OF THE REVITAN STEM IS CONFIRMED BY THE DIFFICULT REMOVAL OF THE DISTAL STEM PART MENTIONED INTRAOPERATIVELY. IT IS POSSIBLE THAT A LACK OF OSTEOINTEGRATION OF THE REVITAN STEM THAT HAS BEEN RADIOLOGICALLY RECOGNIZABLE SINCE THE PRIMARY IMPLANTATION HAS CONTRIBUTED TO AN OVERLOAD OF THE CONNECTION PIN WITH A SUBSEQUENT BREAKAGE OF THE REVITA STEM SEVEN YEARS AFTER IMPLANTATION. WHETHER THE MEDIAL TILTING OF THE PROXIMAL STEM PORTION LED TO THE BREAKAGE OF A PROXIMAL CERCLAGE OR WHETHER THE BREAKAGE OF A PROXIMAL WIRE CERCLAGE WAS PRE-EXISTING CAN NOT BE RELIABLY ASSESSED ON THE BASIS OF THE AVAILABLE DOCUMENTS. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE AND/OR PREVENTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT REOCCURRENCE OF POTENTIAL PIN BREAKAGES OF THE REVITAN REVISION HIP SYSTEM IN THE FUTURE. ZIMMER GMBH DECIDED TO INITIATE A FIELD ACTION IN ORDER TO PROACTIVELY INFORM THE SURGEONS ABOUT HIGH RISK PATIENTS AS THEY MIGHT NOT BE AWARE OF THE EXPLICIT WARNING IN THE IFU. THE ACTION WAS INITIATED ON JANUARY 13TH 2017. AS THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCTS: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14; ITEM#: 0100402055, LOT#: 2561839. UNKNOWN HEAD HIP IMPL, ITEM#: UNKNOWN, LOT#: UNKNOWN. UNKNOWN DURASUL INLAY, ITEM#: UNKNOWN, LOT#: UNKNOWN. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. X-RAYS, SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON JUNE 26, 2018 TO THE APPROPRIATE REPRESENTATIVES. 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 A PATIENT WAS IMPLANTED AND SUBSEQUENTLY, APPROXIMATELY EIGHT YEARS POST IMPLANTATION THE PATIENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600954 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140 N/A KWA ZIMMER GMBH N/A 2557305

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R