BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD HIP IMPLANT

    MDR report key: 6416596 · Received March 20, 2017

    Report

    Report Number
    0009613350-2017-00410
    Event Type
    Injury
    Date Received
    March 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE IS NOT AT HAND FOR INVESTIGATION. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER IS AVAILABLE. EVENT SUMMARY: IT IS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO INFECTION AFTER AN UNKNOWN TIME IN-VIVO. METASUL HEAD AND LINER WERE REMOVED, A WASH OUT WAS PERFORMED AND A POLY LINER WITH CERAMIC HEAD WERE IMPLANTED. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING DFMEA: INFECTION DUE TO NON STERILE HEAD IMPLANT DUE TO INCORRECT STERILIZATION METHOD => NOT POSSIBLE: STERILIZATION METHOD IS VALIDATED ACCORDING TO THE STERILIZATION SPECIFICATION. INFECTION DUE TO NON STERILE HEAD IMPLANT DUE TO INADEQUATE PACKAGING LEADING TO UNSTERILE IMPLANT => NOT POSSIBLE: PACKAGING OF THE PRODUCT IS MANUFACTURED ACCORDING TO THE PACKAGING SPECIFICATION. SEPTIC LOOSENING DUE TO RESTERILIZATION METHOD AS SUGGESTED IN IFU FAILS => POSSIBLE: CORRECT RESTERILIZATION METHOD IS EXPLAINED IN THE IFU AND IT IS NOT UNDER CONTROL OF ZIMMER BIOMET. CONCLUSION SUMMARY. PRODUCT REF/LOT NUMBERS ARE UNKNOWN. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. NO DOCUMENTS CONFIRMING THE OBSERVED INFECTION WERE RECEIVED. STERILIZATION CERTIFICATES OF THE METASUL HEAD AND LINER COULD NOT BE REVIEWED DUE TO ABSENCE OF LOT NUMBERS. NEVERTHELESS, GAMMA STERILIZATION SPECIFICATION OF THE DEVICES CERTIFY THE SUITABILITY OF STERILIZATION. 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. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THIS PRODUCT FAMILY AND IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS (B)(4) STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, 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 (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN UNKNOWN METASUL HEAD HIP IMPLANT ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO INFECTION. THE METASUL HEAD AND LINER WERE REMOVED, A WASHOUT WAS PERFORMED AND A POLY LINER AND CERAMIC HEAD WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200171 METASUL HEAD HIP IMPLANT METASUL HEAD KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R