BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 6, TAPER 12/14

    MDR report key: 5903042 · Received August 25, 2016

    Report

    Report Number
    0009613350-2016-01157
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    July 5, 2016
    Report Date
    August 5, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS 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. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 18, 2016. ADDITIONAL: AGE/DATE OF BIRTH, SEX. UPDATES: DESCRIBE EVENT OR PROBLEM, MODEL #/LOT #, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, ADDITIONAL MFR NARRATIVE. 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).

    Additional Manufacturer Narrative · 1

    UPDATE: DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. THE DEVICES HAVE BEEN REQUESTED AT THE HOSPITAL, HOWEVER THEY WERE NOT RETURNED FOR INVESTIGATION. TREND ANALYSIS: NO TREND IDENTIFIED. A TREND IS IDENTIFIED IF AT LEAST ONE OF THE FOLLOWING CRITERIA IS MET: THREE (3) SIMILAR EVENTS WITHIN 1 MONTH FOR THE SAME ITEM NUMBER. SIX (6) SIMILAR EVENTS WITHIN 6 MONTHS FOR THE SAME ITEM NUMBER. TWO (2) SIMILAR EVENTS FOR THE SAME LOT NUMBER. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT IS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2016 AND WAS REVISED ON (B)(6) 2016 DUE TO INFECTION OF ENTEROCOCCUS FAECALIS. 4 COMPLAINTS FROM THE SAME HOSPITAL "(B)(6)" WERE OPENED FOR REVISION DUE TO INFECTION OF ENTEROCOCCUS FAECALIS: (B)(4). REVIEW OF RECEIVED DATA TWENTY-NINE (29) X-RAYS WERE PROVIDED FOR INVESTIGATION. SIXTEEN (16) X-RAYS SHOW THE PREOPERATIVE SITUATION AND THE PREOPERATIVE SURGICAL PLANNING WITH AN AVENIR STEM. FIVE (5) X-RAYS SHOW THE RIB CAGE OF THE PATIENT. EIGHT (8) X-RAYS SHOW THE RIGHT HIP OF THE PATIENT ONCE THE HIP REPLACEMENT IS PERFORMED. NOTHING CONSPICUOUS WITH REGARDS TO THE REPORTED PATIENT INFECTION CAN BE NOTED ON THE X-RAYS. - NO SURGICAL NOTES WERE PROVIDED. PATIENT HAS HISTORY OF ACUTE RENAL FAILURE AFTER PRIMARY IMPLANTATION AND BILATERAL HIP REPLACEMENT. DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION - THE IRRADIATION AND ETO STERILIZATION CERTIFICATE OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION. - NO FURTHER COMPLAINT REGARDING INFECTION HAS BEEN REPORTED FOR THE PRODUCT LOT NUMBERS AFFECTED IN THE COMPLAINT. ROOT CAUSE ANALYSIS THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE AND ETO STERILIZATION SPECIFICATION CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE AND ETO PROCESSING CERTIFICATE OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THESE PRODUCT REFERENCE NUMBERS. ADDITIONALLY, NO FURTHER COMPLAINT REGARDING INFECTION HAS BEEN REPORTED FOR THE PRODUCT LOT NUMBERS AFFECTED IN THE COMPLAINT. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT OR PACKAGING DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS D011500200 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.". IT HAS TO BE NOTED THAT 4 COMPLAINTS FROM THE SAME HOSPITAL "(B)(6)" WERE OPENED FOR REVISION DUE TO INFECTION AND ENTEROCOCCUS FAECALIS. ALL IMPLANTATION SURGERIES WERE PERFORMED BETWEEN (B)(6) 2016. ALL THE PRODUCTS IMPLANTED IN THE 4 PATIENTS HAVE DIFFERENT LOTS AS WELL AS HAVE BEEN STERILIZED IN DIFFERENT LOTS. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE PRODUCTS FAVORED OR CONTRIBUTED TO THE INFECTION. IMPROPER TRANSPORT, STORAGE AND HANDLING OF THE COMPONENT COULD HAVE COMPROMISED THE STERILIZATION OF THE PRODUCTS. HOWEVER, TRANSPORT, STORAGE AND HANDLING OF THE COMPONENTS IS OUTSIDE OF ZIMMER BIOMET CONTROL. TO FURTHER INVESTIGATE THE ISSUE, THE ORDER DATE OF THE PRODUCTS TO THE HOSPITAL WERE CHECKED AND WERE FOUND TO BE RANGING FROM JAN 14, 2016 TO JUN 9, 2016 AND THERE IS NO CONTEMPORARY ORDER FOR AT LEAST ONE PRODUCT OF THE 4 COMPLAINTS. THIS COULD SUGGEST THAT UNTIL THE ARRIVAL TO THE HOSPITAL THE PRODUCTS INVOLVED IN THE 4 COMPLAINTS HAD NO COINCIDENT STEPS AND THAT POTENTIALLY SOMETHING WITH STORAGE AND/OR HANDLING OF THE COMPONENTS OUTSIDE OF ZIMMER BIOMET CONTROL COULD HAVE CONTRIBUTED TO THE REPORTED PATIENT INFECTION WITH ENTEROCOCCUS FAECALIS. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 27, 2016. THE DEVICES WERE NOT RETURNED FOR INVESTIGATION. 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 THE PATIENT WAS IMPLANTED AN AVENIR M܌LER, STEM, LATERAL, UNCEMENTED, HA, 6, TAPER 12/14 ON AN UNKNOWN DATE.THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION AND ENTEROCOCCUS FAECALIS ON AN UNKNOWN DATE.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE RIGHT HIP WAS AFFECTED.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE IMPLANTATION DATE WAS (B)(6) 2016 AND THE PATIENT WAS REVISED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556891 AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 6, TAPER 12/14 AVENIR MULLER STEM LZO ZIMMER GMBH N/A 2841670

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R