BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MÜLLER ROOF REINFORCEMENT RING

    MDR report key: 6607255 · Received June 2, 2017

    Report

    Report Number
    0009613350-2017-00761
    Event Type
    Injury
    Date Received
    June 2, 2017
    Report Date
    June 1, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    MEH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 THEREFORE TRIED TO RECEIVE MORE INFORMATION FOR THIS CASE. WE RECEIVED AN ANSWER EXPLAINING THAT THE AUTHOR IS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION DUE TO DATA PRIVACY POLICY. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. DHR REVIEW: 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. TREND ANALYSIS: IT WAS NOT POSSIBLE TO PERFORM A TREND ANALYSIS, AS THE CATALOGUE NUMBER OF THE DEVICE IS UNKNOWN. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED IN THE JOURNAL ARTICLE, THAT ONE PATIENT, WHICH HAD AN MULLER ACETABULAR ROOF REINFORCEMENT RING IMPLANTED, EXPERIENCED INFECTION AND UNDERWENT REVISION SURGERY. NO OTHER DETAILS ARE AVAILABLE. REVIEW OF RECEIVED DATA: 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 FAILURE OF PACKAGING DUE TO INSUFFICIENT STERILE BARRIER WITHIN STERILITY GUARANTEE => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES AND/OR PACKAGING WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. - INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE DUE TO SUPPLIER PROCESS => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES AND/OR PACKAGING WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. THE STERILIZATION CERTIFICATE OF THE DEVICES COULD NOT BE REVIEWED SINCE THE DEVICES LOT NUMBERS ARE UNKNOWN. THE GAMMA STERILIZATION SPECIFICATION WHICH IS AVAILABLE FOR EVERY PRODUCT FAMILY CERTIFIES THE SUITABILITY OF STERILIZATION. - INFECTION DUE TO FAILURE OF STERILISATION PROCEDURE DUE TO DESIGN OF THE DEVICE => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES AND/OR PACKAGING WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. - INFECTION DUE TO PROPOSED RESTERILIZATION PROCEDURES IN IFU DO NOT PROVIDE STERILITY => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES AND/OR PACKAGING WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. -TRANSMISSION OF INFECTIOUS AGENTS, INFECTION DUE TO REUSE OF THE DEVICE WHICH IS INTENDED FOR SINGLE USE => POSSIBLE: IT IS ONLY KNOWN THAT ONE PATIENT EXPERIENCED INFECTION AND UNDERWENT REVISION SURGERY. IT IS ALSO UNKNOWN WHEN THE INFECTION OCCURRED (WITHIN 1 YEAR POSTOPERATIVELY OR LATER). NO OTHER DETAILS SUCH AS X-RAYS SURGICAL REPORTS, PRODUCTS,PATIENT DATA, HISTORY AND COMPLIANCE ARE AVAILABLE. THEREFORE THIS CANNOT BE EXCLUDED. CONCLUSION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED IN THIS JOURNAL ARTICLE, ONE PATIENT WAS REVISED DUE TO INFECTION. HOWEVER, NO FURTHER DETAILS ABOUT THE EVENT SUCH AS ONSET OF INFECTION ARE AVAILABLE. NEITHER X-RAYS, OPERATIVE NOTES, NOR OFFICE VISIT NOTES WERE RECEIVED FOR A DEEP ASSESSMENT. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. DUE TO SIGNIFICANT LACK OF INFORMATION, AND BASED ON THE INFORMATION AVAILABLE FOR THE INVESTIGATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 IN A JOURNAL ARTICLE THAT ONE PATIENT WAS IMPLANTED WITH A MÜLLER ACETABULAR ROOF REINFORCEMENT RING (CATALOGUE NUMBER UNKNOWN) AND UNDERWENT REVISION SURGERY DUE TO INFECTION. SOURCE: "ARE POROUS TANTALUM CUPS SUPERIOR TO CONVENTIONAL REINFORCEMENT RING?" ANDERS BRÜGGEMANN, ERIK FREDLUND, HANS MALLMIN & NILS P HAILER (2016) ACTA ORTHOPAEDICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389457 UNKNOWN MÜLLER ROOF REINFORCEMENT RING UNKNOWN MEH ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R