BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROVISIONAL LONG FLANGE CAGE, LEFT USE WITH 76/78/80MM SHELLS/68MM LINERS

    MDR report key: 6783969 · Received August 10, 2017

    Report

    Report Number
    0009613350-2017-01047
    Event Type
    Death
    Date Received
    August 10, 2017
    Date of Event
    March 15, 2016
    Report Date
    October 13, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS IS A SPLIT CASE WITH ZIMMER INC. (B)(4) WHICH WAS REPORTED UNDER: (B)(4). ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE: 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: PATIENT DEATH DUE TO RESPIRATORY FAILURE RELATED TO CHONDROSARCOMA. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT HAD AN AVENIR STEM IMPLANTED ON (B)(6) 2014 ON THE LEFT HIP SIDE. ON (B)(6) 2014 THE PATIENT UNDERWENT LEG AMPUTATION AND IMPLANT REMOVAL DUE TO INFECTION AND NECROSIS. PATIENT DIED ON (B)(6) 2016, DUE TO RESPIRATORY FAILURE DUE TO CHONDROSARCOMA, INFECTION AND NECROSIS. IT IS FURTHER REPORTED THAT THE EXTERNAL ILIAC ARTERY WAS OCCLUDED DURING IMPLANT SURGERY, PATIENT FELT NUMBNESS AFTER WAKING UP, WHICH WAS TREATED WITH THROMBECTOMY, WHICH RETURNED BLOOD FLOW TO THE LEG BUT NECROSIS PREVENTED TISSUE RECOVERY. DESPITE FURTHER TREATMENT TO FACILITATE TISSUE HEALING, INFECTION SET IN. REVIEW OF RECEIVED DATA: ON (B)(6) 2017 SOME DOCUMENTATION (SURGICAL REPORTS) WERE RECEIVED. THE DOCUMENTS RECEIVED ARE IDENTIFIED WITH PAGES 49 ¿ 55 AND PAGES 176 ¿ 178. ON THE PAGES 49 ¿ 55, THE SURGICAL PROCEDURES ARE DESCRIBED AND ON PAGES 176 ¿ 178 THE USED PRODUCTS AND SOME SURGERY INFORMATION ARE DESCRIBED. ON PAGE 49, AN EMBOLECTOMY PERFORMED ON (B)(6) 2014 IS DESCRIBED, HOWEVER, ONLY PART OF THE PROCEDURE IS DESCRIBED. ON PAGE 49-51, THE SURGERY PERFORMED ON (B)(6) 2014 IS DESCRIBED. THE SURGERY IS A HEMIPELVECTOMY WITH EXPLORATION OF ARTERIES, RESECTION OF SARCOMA, AND ACETABULAR RECONSTRUCTION. NO COMPLICATIONS ARE NOTED. THE SURGERY IS COMPLEX AND DESCRIBED IN DETAIL. SOME STEPS ARE SUMMARIZED/REPORTED BELOW. AFTER PREPARATION AND APPROACHING THE HIP JOINT, THE FEMORAL HEAD WAS THEN CUT. GIVEN THAT THERE WAS NO TUMOR EXTENSION IN THE FOVEA OR LIGAMENT OF TERES, THE FEMORAL HEAD WAS REMOVED TO GAIN EXPOSURE. FOLLOWING THIS, BASED ON PREOPERATIVE PLANNING, AN OSTEOTOMY WAS MADE THROUGH THE POSTERIOR, INFERIOR ONE-THIRD OF THE ACETABULAR LEAVING ON TUMOR ALL OF THE ANTERIOR AND PART OF THE POSTERIOR COLUMN. A 0.5 MM WAFER OF BONE WAS CUT IN 3 DIMENSIONS IN ORDER TO LEAVE A 5 MM PIECE OF THE POSTERIOR COLUMN THAT LEFT THE SCIATIC NOTCH INTACT IN ORDER TO KEEP THAT COLUMN . FOUR CUTS IN 3 DIMENSIONS WERE THEN MADE, RESECTING ALL THE ANTERIOR COLUMN, THE SUPERIOR DOME, AND THE MAJORITY OF THE POSTERIOR COLUMN AND WALL OF THE ACETABULUM. A SMALL PART OF THE ACETABULAR WALL WAS LEFT. FOLLOWING THIS, ATTENTION WAS THEN TURNED TO THE PUBIC SYMPHYSIS WHERE TUMOR WAS FOUND TO COME UP ALL THE WAY TO THE PUBIC SYMPHYSIS ON RADIOGRAPHS AND THEREFORE, AN OSTEOTOMY WAS MADE THROUGH THE PUBIC SYMPHYSIS ON THE RIGHT PUBIC SYMPHYSIS TO GET GOOD WIDE MARGIN. LATER ON IT IS DESCRIBED THAT 9 LITERS OF BACITRACIN IRRIGATION WAS USED IN ORDER TO THOROUGHLY IRRIGATE THE PUBIC SYMPHYSIS. ATTENTION WAS THEN TURNED TO THE RESIDUAL ACETABULUM WHERE ABOUT ONE-FIFTH OF THE ACETABULUM REMAINED WITH A 5 MM POSTERIOR COLUMN. DR . (B)(6) THEN ASSISTED WITH ACETABULAR RECONSTRUCTION. A SIZE 60 TRABECULAR METAL CUP WAS THEN PLACED IN ANATOMIC POSITION ON THE RESIDUAL POSTERIOR INFERIOR ACETABULAR WALL AND SCREWED INTO THAT POSITION. FOLLOWING THIS, USING TRABECULAR METAL AUGMENTS ON THE REMAINING ILIUM POSTERIOR COLUMN AND ANTERIOR COLUMN AUGMENTS WERE THEN PLACED AND CEMENTED WITH A THIN FILM OF PALACOS CEMENT TO THE TRABECULAR METAL ACETABULUM. LATER ON THE IMPLANTATION OF THE STEM IS DESCRIBED. THE VESSELS WERE PROTECTED AND THE ABDOMINAL WALL WAS CLOSED TO THE REMAINING ILIOPSOAS , ILIACUS AND THE SOFT TISSUE OF THE MEDIAL THIGH . DEEP 19-FRENCH DRAINS WERE THEN PLACED AND THE DRESSING WAS THEN APPLIED . FOLLOWING THIS, A DRESSING WAS THEN PLACED. THE PATIENT WAS TAKING DIRECTLY TO THE INTENSIVE CARE UNIT . ONCE AT THE INTENSIVE CARE UNIT, THERE WAS FOUND TO BE DECREASED PULSES OF THE FOOT IN DP AND PT AREA . DIRECTLY FOLLOWING THIS THE ULTRASOUND TECH CAME AND SHOWED THAT THERE WAS FLOW THROUGH THE SUPERFICIAL FEMORAL ARTERY DOWN INTO THE POPLITEAL FOSSA, BUT IT WAS DIFFICULT IDENTIFY ANY FLOW THROUGH THE POPLITEAL FOSSA. A STAT CT ANGIO WAS ORDERED WHICH SHOWED 3-VESSEL RUNOFF, WHICH WAS A BIT DIMINISHED AND DELAYED. FOLLOWING THIS, AN ANGIOGRAM WAS ORDERED GIVEN THE DELAYED RUNOFF . THERE WAS FOUND TO BE AN AREA OF STENOSIS IN THE COMMON ILIAC ARTERY. AT THIS POINT, VASCULAR SURGERY WAS CONSULTED AND WE DISCUSSED EMBOLECTOMY. IN THE NEXT PAGE, THE EMBOLECTOMY PERFORMED ON (B)(6) 2014 IS DESCRIBED. THE PREVIOUS SURGERY WAS WITHIN HOURS OF THIS. THE PATIENT WAS THEREFORE TAKEN URGENTLY TO THE OPERATING ROOM AFTER I DISCUSSED THIS WITH HER AND HER HUSBAND. THE ILIAC ARTERY IN THE AREA WHERE THIS WAS FOUND TO HAVE A STENOSIS WAS FOUND TO BE PALPABLY THROMBOSED. FOLLOWING THIS, SHE WAS EXAMINED AND FOUND TO HAVE HER FOOT FORCED IN PLANTARFLEXION WHICH SHE HAD NOT HAD ONLY HAD 2 HOURS EARLIER WHEN SHE WAS EXAMINED . GIVEN THAT HER CALF WAS EXTREMELY TAUT AND PAINFUL , WE DECIDED THAT IT WAS NECESSARY TO GO AHEAD WITH 4 COMPARTMENT FASCIOTOMIES. THE WOUNDS WERE THEN THOROUGHLY IRRIGATED AND SALINE SOAKED KERLIX WAS THEN PLACED IN THE WOUNDS AND ACE WRAP WAS PLACED AROUND THEM . THE PATIENT WAS THEN TAKEN URGENTLY BACK TO THE CU TO BE REWARMED. ON PAGE 55, THE SURGERY PERFORMED ON (B)(6) 2014 IS SUMMARIZED. NO ADDITIONAL INFORMATION. - A LEGAL DOCUMENT WAS RECEIVED AND REVIEWED. THE LEGAL DOCUMENT DESCRIBES THE FOLLOWING. ON OR ABOUT (B)(6) 2014 THE PATIENT WAS DIAGNOSED WITH PELVIC CHONDROSARCOMA. AN INTERNAL HEMIPELVECTOMY WAS DONE ON (B)(6) 2014. ZIMMER HIP IMPLANTS WERE IMPLANTED. DURING THE SURGERY THE ILIAC ARTERY WAS OCCLUDED. A SIGNIFICANT PERIOD OF TIME LATER WHEN THE PATIENT AWOKE FROM SURGERY, SHE COMPLAINED OF NUMBNESS IN THE LEFT LEG. THERE WAS NOT SUFFICIENT BLOOD FLOW TO HER LEFT LEG. THE DOCTORS PERFORMED AN EMERGENCY THROMBECTOMY. THE PROCEDURE RETURNED BLOOD FLOW TO THE LEG, BUT NECROSIS PREVENTED TISSUE RECOVERY. OVER THE FOLLOWING MONTHS INFECTION WAS SET IN. FOR AT LEAST 20 DAYS AFTER SURGERY IT WAS FOUND OUT THE PATIENT WAS HALLUCINATING PRIOR TO ADDITIONAL TREATMENT FOR THE NECROSIS AND INFECTION. ON OR ABOUT (B)(6) 2014 THE PATIENT HAD NO ALTERNATIVE OTHER THAN TO HAVE HER LEFT LEG AMPUTATED. THE ZIMMER IMPLANTS WERE ALSO REMOVED. UNFORTUNATELY, THE PATIENT DIED ON (B)(6) 2016 FROM RESPIRATORY FAILURE DUE TO CHONDROSARCOMA, A CONDITION UNTREATABLE DUE TO HER WEAKENED STATE AFTER THE INTERNAL HEMIPELVECTOMY. THE PROXIMATE CAUSE OF HER DEATH WAS INFECTION AND NECROSIS FROM NEGLIGENCE DURING AND AFTER SURGERY ON OR ABOUT (B)(6) 2014 AND ALSO INFECTION CAUSED BY THE ZIMMER HIP IMPLANT. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. 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. - THE PACKAGE INSERT FOR AVENIR MÜLLER STEM SAP D011 500 294 DESCRIBE THE FOLLOWING CONTRAINDICATIONS: - LACK OF BONY STRUCTURES PROXIMAL OR DISTAL TO THE JOINT, SO THAT GOOD ANCHORAGE OF THE IMPLANT IS UNLIKELY OR IMPOSSIBLE. - ANY CONCOMITANT DISEASES THAT CAN JEOPARDIZE THE FUNCTIONING AND THE SUCCESS OF THE IMPLANT. - ALLERGY TO THE IMPLANTED MATERIAL, ESPECIALLY TO METAL (E.G., COBALT, CHROMIUM, NICKEL, ETC.). - LOCAL BONE TUMORS AND/OR CYSTS. WOUND INFECTIONS CAN BE ALSO FOUND IN THE PACKAGE INSERT UNDER ADVERSE EFFECTS WHICH WAS REPORTED IN TOTAL AND HEMI ARTHROPLASTY. REVIEW OF THE EVENT REPORTED BY A HEALTHCARE PROFESSIONAL: IN THE PRESENT CASE, AN INTERNAL HEMIPELVECTOMY ON THE LEFT SIDE WITH IMPLANTATION OF A HIP ENDOPROSTHESIS IS REPORTED FOR A PATIENT SUFFERING FROM A PELVIC CHONDROSARCOMA. POSTOPERATIVELY, A THROMBECTOMY WAS PERFORMED DUE TO INSUFFICIENT BLOOD FLOW OF THE LEFT LEG. ALTHOUGH THE BLOOD FLOW HAD SUBSEQUENTLY RETURNED, NECROSIS HAD PREVENTED THE TISSUE REPAIR. OVER THE FOLLOWING MONTHS REPEATED FRUSTRATING ATTEMPTS FOR TISSUE HEALING HAD BEEN MADE, THE INFECTION HAD SETTLED. 20 DAYS POSTOPERATIVELY THE PATIENT HAD HALLUCINATED; THE PATIENT WAS UNABLE TO GIVE INFORMED CONSENT AT THAT TIME. ON (B)(6) 2014, THE LEFT LEG HAD TO BE AMPUTATED; THE HIP IMPLANTS HAD BEEN REMOVED. ON (B)(6) 2016, THE PATIENT DIED OF RESPIRATORY FAILURE DUE TO THE CHONDROSARCOMA. DISEASE CHONDROSARCOMA: CHONDROSARCOMAS ARE AMONG THE MOST COMMON MALIGNANT BONE TUMORS, THE 5-YEAR SURVIVAL RATE IS ABOUT 70%. IN THE MENTIONED INTERNAL HEMIPELVECTOMY WITH IMPLANTATION OF A HIP ENDOPROSTHESIS IS PROBABLY A BASIN PART RESECTION WITH PORTIONS OF THE ACETABULUM AND JOINT REPLACEMENT. IN THIS CASE IT CAN BE ASSUMED THAT A MASSIVE LESION, WHICH IS PERI OR ACETABULAR AND WHICH INVOLVES RESECTION WITH AN UNSTABLY RESULTING BONE LOSS, REQUIRES A RECONSTRUCTION TECHNIQUE WITH A HIP ARTHRODESIS. AN OPERATING PROCEDURE ON THE PELVIS ALWAYS INVOLVES AN INCREASED COMPLICATION RATE. WOUND HEALING DISORDERS ARE ALSO FOUND IN THE LITERATURE OF INTERNAL HEMIPELVECTOMIES WITHOUT ENDOPROSTHETIC JOINT REPLACEMENT. DEEP VENOUS THROMBOSIS IS ONE OF THE MOST SERIOUS PERIOPERATIVE COMPLICATIONS AFTER HIP PROSTHESIS IMPLANTATION. THE TOTAL THROMBOSIS RATE AND THE THIGH THROMBOSIS RATE CAN BE SIGNIFICANTLY REDUCED IN POSTOPERATIVE PREVENTION. IN THE PRESENT CASE, THE PATIENT WAS INFORMED ABOUT THE RISKS FOR THROMBOSIS AND THE PERFORMED THROMBECTOMY. NEARLY ALL PATIENTS ARE POSTOPERATIVELY RELYING ON MOBILE AIDS AFTER PERFORMED HEMIPELVECTOMY. THE PATIENT DIED OF RESPIRATORY FAILURE DUE TO CHONDROSARCOMA. IN THE LITERATURE, THIS IS ALSO DESCRIBED AS DISTANT METASTASES IN THE LUNG. - THE INTERNAL DOCUMENTS WERE REVIEWED. THE STERILIZATION CERTIFICATES FOR LOT 4021843, 2667262 AND 2621739 HAVE BEEN REVIEWED AND NO DEVIATIONS AND/OR ABNORMALITIES HAVE BEEN FOUND. THIS MEANS A SAFETY MARGIN OF 10-6 CAN BE CONFIRMED. THE DHR (DEVICE HISTORY RECORDS) INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THEREFORE IT CAN BE CONCLUDED THAT THE DEVICE WAS ACCORDING TO PRODUCT SPECIFICATION. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: - ADVERSE BODY REACTION (E.G. CANCER, ALLERGIES, ETC.) DUE TO MATERIAL NOT BIOCOMPATIBLE => NOT POSSIBLE: THERE IS A BIOCOMPATIBILITY SPECIFICATION. - SEPTIC LOOSENING DUE TO INFECTION DUE TO UNSTERILE IMPLANT (FAILURE OF STERILIZATION PROCEDURE AT SUPPLIER DUE TO DESIGN) => NOT POSSIBLE: THERE ARE STERILIZATION SUMMARY AND GAMMA SPECIFICATION. - ADVERSE BODY REACTION DUE TO LEACHING OF CRITICAL SUBSTANCES (E.G. PLASTICIZERS, PHTHALATES) => NOT POSSIBLE: THERE IS A BIOCOMPATIBILITY SPECIFICATION AND MATERIAL COMPATIBILITY SPECIFICATION. - LINE 59 : INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE DUE TO SUPPLIER PROCESS => NOT POSSIBLE: THERE ARE STERILIZATION SUMMARY AND GAMMA SPECIFICATION. - TRANSMISSION OF INFECTIOUS AGENTS, INFECTION DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE => POSSIBLE: IT IS POSSIBLE THAT THE DEVICE WAS RE-USED IN THE HOSPITAL. CONCLUSION SUMMARY IT WAS REPORTED THAT A PATIENT HAD AN AVENIR STEM IMPLANTED ON (B)(6) 2014 ON THE LEFT HIP SIDE. ON (B)(6) 2014 PATIENT UNDERWENT LEG AMPUTATION AND IMPLANT REMOVAL DUE TO INFECTION AND NECROSIS. PATIENT DIED ON (B)(6) 2016, DUE TO RESPIRATORY FAILURE DUE TO CHONDROSARCOMA. IT IS FURTHER REPORTED THAT THE EXTERNAL ILIAC ARTERY WAS OCCLUDED DURING IMPLANT SURGERY, PATIENT FELT NUMBNESS AFTER WAKING UP, WHICH WAS TREATED WITH THROMBECTOMY, WHICH RETURNED BLOOD FLOW TO THE LEG BUT NECROSIS PREVENTED TISSUE RECOVERY. DESPITE FURTHER TREATMENT TO FACILITATE TISSUE HEALING, INFECTION SET IN. THE INTERNAL DOCUMENTS WERE REVIEWED. THE STERILIZATION CERTIFICATES FOR LOT 4021843, 2667262 AND 2621739 HAVE BEEN REVIEWED AND NO DEVIATIONS AND/OR ABNORMALITIES HAVE BEEN FOUND. THIS MEANS A SAFETY MARGIN OF 10-6 CAN BE CONFIRMED. THE DHR (DEVICE HISTORY RECORDS) INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THEREFORE IT CAN BE CONCLUDED THAT THE DEVICE WAS ACCORDING TO PRODUCT SPECIFICATION. CHONDROSARCOMAS ARE AMONG THE MOST COMMON MALIGNANT BONE TUMORS. AN OPERATING PROCEDURE ON THE PELVIS ALWAYS INVOLVES AN INCREASED COMPLICATION RATE. WOUND HEALING DISORDERS ARE ALSO FOUND IN THE LITERATURE OF INTERNAL HEMIPELVECTOMIES WITHOUT ENDOPROSTHETIC JOINT REPLACEMENT. DEEP VENOUS THROMBOSIS IS ONE OF THE MOST SERIOUS PERIOPERATIVE COMPLICATIONS AFTER HIP PROSTHESIS IMPLANTATION. THE TOTAL THROMBOSIS RATE AND THE THIGH THROMBOSIS RATE CAN BE SIGNIFICANTLY REDUCED IN POSTOPERATIVE PREVENTION. IN THE PRESENT CASE, THE PATIENT WAS INFORMED ABOUT THE RISKS FOR THROMBOSIS AND THE PERFORMED THROMBECTOMY. HOWEVER, BASED ON THE GIVEN INFORMATION AND PERFORMED INVESTIGATION, THERE IS NO EVIDENCE FOR AN IMPLANT FAILURE/ISSUE WHICH COULD HAVE INFLUENCED THE PATIENT¿S DEATH. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 1, TAPER 12/14 ON THE LEFT SIDE ON (B)(6) 2014 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO NOT SUFFICIENT BLOOD FLOW AND THEREFORE NUMBNESS IN THE LEFT LEG. ON (B)(6) 2016 THE PATIENT DIED APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO RESPIRATORY FAILURE RELATED TO CHONDROSARCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564627 PROVISIONAL LONG FLANGE CAGE, LEFT USE WITH 76/78/80MM SHELLS/68MM LINERS JDI ZIMMER GMBH N/A 2621739

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| H| R