BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HOODED, HH/28

    MDR report key: 7454297 · Received April 24, 2018

    Report

    Report Number
    0009613350-2018-00464
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    August 25, 2015
    Report Date
    July 4, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    ATTORNEY

    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: INFECTION, METALLOSIS. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT HAD A HIP PROSTHESIS IMPLANTED ON THE LEFT HIP SIDE ON (B)(6) 2013, WHICH WAS REVISED ON AUGUST 25, 2015 DUE TO STEM LOOSENING AND INFECTION (SEE ALSO SPLIT CASE CMP-0361474). THE CUP REMAINED IMPLANTED. REVIEW OF RECEIVED DATA: THE REVISION REPORT DATED ON AUGUST 25, 2015 HAS BEEN RECEIVED. THE PATIENT HAS BEEN REVISED DUE TO AN ASEPTIC LOOSENING OF THE STEM, WHICH HAS BEEN IMPLANTED ON JUNE 7, 2013. AN INFECTION COULD NOT BE DETECTED PRIOR TO THE REVISION SURGERY. THE INLAY, STEM AND HUMERAL HEAD HAVE BEEN REVISED. A BLACK FLUID WITH METAL PARTICLES WAS FOUND. THE ALLOFIT ALLOCLASSIC SHELL REMAINED IMPLANTED. FURTHER MEDICAL RECORDS HAVE BEEN RECEIVED. IT IS MENTIONED, THAT PRE-OPERATIVE NO INFECTION COULD BE DIAGNOSED. TWO OF THE FIVE TISSUE SAMPLES WHICH HAVE BEEN TAKEN DURING REVISION SURGERY ON AUGUST 25, 2015 PROVED THAT PATIENT HAD SUFFERED A LOW-GRAD INFECTION OF STAPHYLOCOCCUS EPIDERMIDIS. ADDITIONAL INFORMATION CONCERNING PATIENT HISTORY: PATIENT HAS BEEN IMPLANTED WITH PACEMAKER IN 2012. - SIX X-RAYS AND ONE SCREEN-SHOT OF AN X-RAY HAVE BEEN RECEIVED. ALL ARE DATED PRIOR TO THE REVISION SURGERY IN AUGUST 2015. LARGE RADIAL LUCENCY/OSTEOLYSIS HAS BEEN FOUND ABOUT THE ACETABULAR CUP, WHICH MAY BE DUE TO INFECTION OR PARTICLE DISEASE. MOREOVER, FAT PLANES LATERAL TO THE HIP ARE OBSCURED WHICH MAY BE DUE TO INFLAMMATION OR MASS. ADDITIONALLY THERE IS A MEDIAL PROTUSION OF THE ACETABULAR CUP. THE STEEP ACETABULAR LATERAL ANGLE OF INCLINATION (48°) MAY BE A RISK FACTOR FOR DISLOCATION AND PARTICLE DISEASE. - IMPLANT STICKERS: THE IMPLANT STICKERS OF THE IMPLANTATION SURGERY FROM JUNE 07, 2013 HAVE BEEN RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - INSTRUCTION FOR USE (IFU): THE PACKAGING INSERT IFU FOR ENDOPROSTHESIS D011500200 HAS BEEN REVIEWED. IT STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. ADDITIONALLY, IT IS STATED THAT "BEFORE STERILE IMPLANTS ARE REMOVED FROM THEIR PACKAGING, THE PROTECTIVE WRAPPING MUST BE EXAMINED FOR POSSIBLE DAMAGE AS THIS COULD JEOPARDIZE THEIR STERILITY." AND "IF THE PACKAGING IS DAMAGED OR THE STERILITY EXPIRATION DATE HAS BEEN REACHED, THE IMPLANTS MUST BE RETURNED TO THE MANUFACTURER.". - THE INTERNAL DOCUMENTS OF THE PRODUCTS WERE REVIEWED. THE DHR (DEVICE HISTORY RECORDS) INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THEREFORE IT CAN BE CONCLUDED THAT THE DEVICES WERE ACCORDING TO PRODUCT SPECIFICATIONS. THE STERILIZATION CERTIFICATES FOR LOT 2700921 , 2687025 AND 2694526 HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATIONS. ADDITIONALLY, THE PRODUCT HISTORIES HAS BEEN REVIEWED: ALLOFIT CUP: THERE IS ONE ADDITIONAL REPORTED EVENT FOR THE PRODUCT LOT NUMBER AFFECTED IN THE COMPLAINT, HOWEVER THIS COMPLAINT IS TREATING THE SAME PATIENT AND PRODUCT (CMP-0361475, FURTHER INFECTION). DURASUL ALPHA INSERT: NO ADDITIONAL REPORTED EVENT FOR THE PRODUCT LOT NUMBER COULD BE FOUND. SULOX HEAD: NO ADDITIONAL REPORTED EVENT FOR THE PRODUCT LOT NUMBER COULD BE FOUND. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW (SULOX HEAD): - NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE => NOT POSSIBLE -> THE STERILIZATION CERTIFICATE FOR LOT 2694526 HAS BEEN REVIEWED. MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE => NOT POSSIBLE -> ALL DEVICES ARE PROCESSED ACCORDING TO PACKAGING SPECIFICATION (SULOX HEADS). MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - SYSTEMIC ADVERSE BODY REACTIONS DUE TO CONTAMINATED DEVICE DUE TO INSUFFICIENT INTERNAL CLEANING PROCESS => NOT POSSIBLE -> THE STERILIZATION CERTIFICATE FOR LOT 2694526 HAS BEEN REVIEWED. MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, IMPLANT BREAKAGE, CORROSION, METALOSIS, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO HEAD IS IMPLANTED ON A DAMAGED STEM TAPER; USAGE OF A WET AND/OR UNCLEAN STEM AND/OR HEAD TAPER (PARTICLES BETWEEN STEM TAPER AND BALL HEAD TAPER) => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THE INSTRUCTION GIVEN IN IFU (CHAPTER: "GENERAL INSTRUCTIONS" AND "IMPORTANT INFORMATION FOR THE USERS OF ZIMMER HIP SYSTEMS WITH METASUL METAL PAIRINGS OR CERASUL CERAMIC PAIRINGS"). - NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THE INSTRUCTION GIVEN IN IFU (CHAPTERS:"STERILIZATION INSTRUCTIONS") NEED TO BE FOLLOWED. - NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THE INSTRUCTION GIVEN IN IFU (CHAPTERS:"WARNINGS", "STERILIZATION INSTRUCTIONS") NEED TO BE FOLLOWED. ROOT CAUSE DETERMINATION USING RMW (SHELL) : - METAL DEBRIS, BREAKAGE OF INSERT, STEM NECK FRACTURE, DISLOCATION OR LUXATION,OSTEOLYSIS / METALLOSIS DUE TO INAPPROPRIATE DESIGN CONCERNING RANGE OF MOTION LEADING TO IMPINGEMENT OF COMPONENTS => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT - ASEPTIC LOOSENING, METALLOSIS, SOFT TISSUE DAMAGE DUE TO METAL PARTICLE WEAR DUE TO MICRO MOTION BETWEEN SHELL AND POLAR PLUG => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - ASEPTIC LOOSENING, METALLOSIS, SOFT TISSUE DAMAGE DUE TO METAL PARTICLE WEAR DUE TO MICRO MOTION BETWEEN SHELL AND SCREW PLUG => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - ASEPTIC LOOSENING, METALLOSIS, SOFT TISSUE DAMAGE DUE TO METAL PARTICLE WEAR DUE TO MICRO MOTION BETWEEN SHELL AND BONE SCREW HEAD => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - NON-STERILE DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE => NOT POSSIBLE -> THE STERILIZATION CERTIFICATE FOR LOT 2700921 HAS BEEN REVIEWED. MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE AT SUPPLIER => NOT POSSIBLE -> THE STERILIZATION CERTIFICATE FOR LOT 2700921 HAS BEEN REVIEWED. MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE => NOT POSSIBLE -> ALL DEVICES ARE PROCESSED ACCORDING TO PACKAGING SPECIFICATION. MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - SYSTEMIC ADVERSE BODY REACTIONS DUE TO CONTAMINATED DEVICE DUE TO INSUFFICIENT INTERNAL CLEANING PROCESS => NOT POSSIBLE -> THE STERILIZATION CERTIFICATE FOR LOT 2700921 HAS BEEN REVIEWED. MOREOVER, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - DESIGN SPECIFICATION NOT MET DUE TO INCORRECT OR INAPPROPRIATE FUNCTIONAL SURFACE CHARACTERISTICS (E.G. PROTUDING BURRS) => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - NON-STERILE DEVICE IS IMPLANTED DUE TO INADEQUATE TRANSPORT/HANDLING/STORAGE CONDITION => POSSIBLE, TRANSPORTATION, HANDLING AND STORAGE OF THE PRODUCTS IN THE HOSPITAL IS OUT OF ZIMMER BIOMET CONTROL. HOWEVER, ALL PRODUCTS SHOULD BE CHECKED FOR PACKAGING DAMAGES OR DEFORMATION UPON RECEIPT. - NON-STERILE DEVICE IS IMPLANTED DUE TO INADEQUATE RE-STERILIZATION PROCEDURE BY USER => POSSIBLE, POTENTIAL RE-STERILIZATION PROCEDURE IN THE HOSPITAL IS UNKNOWN. HOWEVER, INSTRUCTIONS ARE GIVEN IN THE IFU (SECTIONS STERILITY, RE-STERILIZATION; STORAGE AND HANDLING). - NON-STERILE DEVICE IS IMPLANTED DUE TO IMPLANT IS FALLING TO FLOOR DURING HANDLING IN OR => POSSIBLE, AS IT CANNOT BE EXCLUDED. HOWEVER, INSTRUCTIONS ARE GIVEN IN THE IFU (SECTION WARNINGS). - NON-STERILE DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY => POSSIBLE, AS IT CANNOT BE EXCLUDED. HOWEVER, INSTRUCTIONS ARE GIVEN IN THE IFU (SECTIONS WARNINGS, STORAGE AND HANDLING). ROOT CAUSE ANALYSIS WITH DFMEA (DURASUL INLAY): - INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE DUE TO SUPPLIER PROCESS => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE DUE TO DESIGN => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INFECTION DUE TO RE-USE OF SINGLE USE COMPONENTS => POSSIBLE: IT IS UNKNOWN IF THE DEVICES WERE RE-USED OR RE-STERILIZED. THUS, IT CANNOT BE EXCLUDED. CONCLUSION SUMMARY: IT WAS REPORTED THAT A PATIENT HAD A HIP PROSTHESIS IMPLANTED ON THE LEFT HIP SIDE ON JUNE 07, 2013, WHICH WAS REVISED ON AUGUST 25, 2015 DUE TO STEM LOOSENING AND INFECTION (SEE ALSO SPLIT CASE 0361474). THE CUP REMAINED IMPLANTED. THE PATIENT RECEIVED A PACEMAKER IN 2012. CARDIOLOGY DISORDERS MIGHT POTENTIALLY BE A RISK FACTOR FOR PERIPROSTHETIC JOIN INFECTIONS SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THE KNOWN PRODUCT REFERENCE NUMBERS. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT OR PACKAGING DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. ADDITIONALLY, IT IS STATED THAT "BEFORE STERILE IMPLANTS ARE REMOVED FROM THEIR PACKAGING, THE PROTECTIVE WRAPPING MUST BE EXAMINED FOR POSSIBLE DAMAGE AS THIS COULD JEOPARDIZE THEIR STERILITY." AND "IF THE PACKAGING IS DAMAGED OR THE STERILITY EXPIRATION DATE HAS BEEN REACHED, THE IMPLANTS MUST BE RETURNED TO THE MANUFACTURER.". AS THE PRODUCT HAS NOT BEEN RETURNED FOR AN INVESTIGATION, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, BASED ON THE GIVEN INFORMATION AND PERFORMED INVESTIGATION, THERE IS NO EVIDENCE FOR AN IMPLANT FAILURE WHICH COULD HAVE INFLUENCED THE REPORTED EVENT. NEITHER THE DEVICES NOR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED METAL PARTICLES WHICH HAVE BEEN FOUND DURING REVISION SURGERY. THE STEEP ACETABULAR LATERAL ANGLE OF INCLINATION (48°) MAY BE A RISK FACTOR FOR DISLOCATION AND PARTICLE DISEASE. HOWEVER, AN EXACT ROOT CAUSE FOR THE METAL PARTICLES CANNOT BE DETERMINED. 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).

    Description of Event or Problem · 0

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT DURING A STEM REVISION AN INFECTION HAS BEEN DETECTED. THE HEAD AND THE INSERT,HAVE BEEN REVISED. THE SHELL REMAINS IMPLANTED. NOTE: THE FOLLOWING CASES WERE REPORTED FOR THE SAME PATIENT: - (B)(4): REVISION OF THE STEM DUE TO LOOSENING, CASE FROM ZIMMER INC., WARSAW, MFR-0001822565-2018-00729. - (B)(4): FURTHER INFECTION IN 2016, MFR-0009613350-2018-00234.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: ALLOFIT ALLOCLASSIC SHL 50/HH, CATALOG #: 4244, LOT #: 2700921; ITEM: SULOX, HEAD, S, 28/- 3.5, TAPER 12/14, CATALOG #: 17.28.05, LOT #: 2694526. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. X-RAYS AND SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON MARCH 28, 2018 TO THE APPROPRIATE REPRESENTATIVES. PRODUCT TO RETURN? IF NO, WHY NOT? 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. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURAL ALPHA INSERT NEUTR GG/32 01.00013.407) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00465, 0009613350 - 2018 - 00466. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE SAME PATIENT HAD ANOTHER INFECTION, CAPTURED IN (B)(4). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(6) REFERENCE NUMBER (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 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 K013935. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, 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 DURING A STEM REVISION AN INFECTION HAS BEEN DETECTED. THE DURASUL, ALPHA INSERT, HOODED, HH/28 WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297620 DURASUL, ALPHA INSERT, HOODED, HH/28 N/A JDI ZIMMER GMBH N/A 2687025

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R