BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDULLARY PLUG WITH DRAIN 3.5

    MDR report key: 4894037 · Received July 2, 2015

    Report

    Report Number
    9613350-2015-00717
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION USED IS APPROVED BY ZIMMER. REVIEW OF INCOMING INFORMATION: BASED ON THE AVAILABLE INFORMATION IT CANNOT BE ASSESSED WHY A (B)(6) PATIENT WENT INTO CARDIAC ARREST AND WAS UNABLE TO BE RESUSCITATED 10-15 MIN AFTER THE REMOVAL OF STEM AND CEMENT. THE CONCLUSION CAN BE ONLY HYPOTHETICAL. IT IS NOT KNOWN WHETHER THE PATIENT WAS AT CARDIAC RISK OR EVEN IF A CONNECTION EXISTS FOR CEMENTING. IF THERE WAS A CONNECTION FOR CEMENTING THE FEMUR, IT WOULD BE RELEVANT TO KNOW WHETHER THE SURGEON PERFORMED A MEDULLARY CAVITY LAVAGE PRIOR TO CEMENTING. IN NUMEROUS PUBLICATIONS IT HAS BEEN ADVISED OF THE PROBLEMS OF THROMBOEMBOLIC COMPLICATIONS. ADDITIONALLY PATHOPHYSIOLOGICAL CAUSES WERE RECOGNIZED EARLY IN THE CONTEXT OF INTRAVASATION OF THROMBOEMBOLIC PARTICLES DURING PROSTHESIS IMPLANTATION. INTRAMEDULLARY PRESSURE MEASUREMENTS SHOWED HIGH PRESSURE PEAKS THAT CAN BE SEEN IN A CAUSAL RELATIONSHIP. MASSIVE INTRAVASATION OF BONE MARROW CONSTITUENTS OCCUR RELATIVELY RARE, BUT CAN CAUSE A FATAL CARDIOVASCULAR IMPAIRMENT IN THE SENSE OF THROMBOEMBOLIC COMPLICATIONS. PERI- AND POST-OPERATIVE PULMONARY EMBOLISM IS THE MOST FREQUENT CAUSE OF DEATH DURING THE CEMENTED HIP-IMPLANTATION NOWADAYS. AT THE PRESENT STATE OF RECORDED KNOWLEDGE, THE INCREASE IN INTERMEDULLARY PRESSURE (IMD) AND THE AMOUNT OF POTENTIALLY THROMBOGENIC MATERIAL IN THE FEMORAL SHAFT CONSTITUTE THE DECISIVE FACTORS IN THE PATHOPHYSIOLOGICAL MECHANISM FOR THE FORMATION OF BONE MARROW EMBOLISMS DURING THE SURGERY. THE JET LAVAGE (HIGH PULSATILE LAVAGE) IS THUS A TECHNIQUE WHICH PROVIDES BENEFITS IN BOTH THE BIOMECHANICAL PURPOSES AND TO AVOID EMBOLIZATION. REVIEW OF INTERNAL DOCUMENTS: STERILIZATION CERTIFICATE OF THE MEDULLARY PLUG WITH DRAIN WAS REVIEWED. THE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING TO THE SPECIFICATIONS. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: A) LINE 8: ADVERSE BODY REACTION -> DUE TO BREAKAGE OF DRAIN DURING REMOVAL B) LINE 9: ADVERSE BODY REACTION -> DUE TO MATERIAL NOT COMPATIBLE TO IMPLANT OR DISTAL CENTRALIZER (MS-30 STEM) C) LINE 10: ADVERSE BODY REACTION -> DUE TO MATERIAL NOT COMPATIBLE TO BONE CEMENT D) LINE 14: ADVERSE BIOLOGICAL REACTION (INCLUDING CANCER) -> DUE TO LEAKAGE OF SUBSTANCES WHICH ARE CARCINOGENIC, MUTAGENIC, OR TOXIC TO REPRODUCTION E) LINE 15: INFECTION -> DUE TO INFECTION FROM UNSTERILE IMPLANT DUE TO FAILURE OF PACKAGING F) LINE 16: ADVERSE BIOLOGICAL REACTION -> DUE TO MATERIAL NOT BIOCOMPATIBLE, CAUSES SHORT- AND LONG-TERM ADVERSE BIOLOGICAL REACTIONS (INCLUDING LEACHABLES) G) LINE 20: INFECTION -> DUE TO CONTAMINATION DURING HANDLING IN OR COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: A) LINE 8: NOT POSSIBLE -> THE REPORTED EVENT DOES NOT INDICATE ANY REMOVAL OF THE MEDULLARY PLUG. B) LINE 9: NOT POSSIBLE -> MATERIAL COMPATIBILITY IS VALIDATED ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION C) LINE 10: NOT POSSIBLE -> MATERIAL COMPATIBILITY IS VALIDATED ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION D) LINE 14: NOT POSSIBLE -> MATERIAL COMPATIBILITY IS VALIDATED ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION E) LINE 15: POSSIBLE -> EVEN THOUGH PACKAGING IS VALIDATED ACCORDING TO PACKAGING SPECIFICATION, WRONG HANDLING OF THE PRODUCT IS OUT OF ZIMMER BIOMET CONTROL. F) LINE 16: NOT POSSIBLE -> BIOCOMPATIBILITY OF THE DEVICE IS VALIDATED ACCORDING TO BIOCOMPATIBILITY SPECIFICATION G) LINE 20: POSSIBLE -> WRONG HANDLING OF THE DEVICE IS OUT OF ZIMMER BIOMET CONTROL NEITHER X-RAYS, OPERATIVE NOTES, NOR DEVICES OR PHOTOS OF THE IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE IMPLANTATION PROCEDURE SUCH AS BONE QUALITY OR RELEVANT MEDICAL HISTORY ARE UNKNOWN. ANAESTHESIA PROTOCOL AND TREATMENT PLAN IS UNAVAILABLE. COMPLAINT HISTORY SEARCH BASED ON THE COMPLAINTS RECORDED SINCE THE BEGINNING OF DOCUMENTATION SHOWED NO SIMILAR CASES FOR THE PRODUCTS EMPLOYED IN THE SURGERY. DEVICE MANUFACTURING HISTORY RECORDS OF THE DEVICES INDICATE THAT THE RELEASED COMPONENTS FROM THE RESPECTIVE BATCHES MET ALL REQUIREMENTS TO PERFORM AS INTENDED. STERILIZATION CERTIFICATES OF THE DEVICES SHOW THAT THE ARTICLES WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS NOT SUSPECTED THAT THE PRODUCTS CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. BASED ON THE DEVICE HISTORY RECORDS, COMPLAINT HISTORIES OF THE RELEVANT PRODUCTS, STERILIZATION CERTIFICATES AND HEALTH CARE PROFESSIONAL'S REVIEW ON THE CASE THERE IS NO INDICATION THAT THE INVOLVED ZIMMER PRODUCTS CONTRIBUTED TO THE EVENT. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT A MEDULLARY PLUG WITH DRAIN 3.5 SHOULD BE IMPLANTED ON (B)(6) 2015. DURING THE PROCEDURE, THE SURGEON PREPARED THE FEMUR FOR AN MS30 CEMENTED FEMORAL STEM. SURGEON BROACHED TO A SIZE 12 BROACH AND TRIALLED A STD OFFSET CONFIGURATION WITH THE MULTIPOLAR. THE TRIAL BROACH SAT APPROPRIATELY IN THE FEMUR. THE SURGEON INTRODUCED CEMENT INTO THE FEMORAL CANAL. DURING DEFINITIVE STEM INSERTION, SURGEON WAS UNABLE TO FULLY SEAT IMPLANT WITH THE IMPLANT SITTING UP BY APPROX 10 MM. DECISION WAS MADE BY SURGEON TO REMOVE MS30 STEM AND CEMENT FROM THE FEMORAL CANAL PRIOR TO CEMENT SETTING. AFTER APPROX 10-15 MINUTES AFTER THE STEM AND CEMENT WERE REMOVED, PATIENT WENT INTO CARDIAC ARREST AND WAS UNABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433162 MEDULLARY PLUG WITH DRAIN 3.5 MEDULLARY PLUG LZN ZIMMER GMBH NA 2793258

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death