BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, MM/36

    MDR report key: 6933719 · Received October 10, 2017

    Report

    Report Number
    0009613350-2017-01414
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    January 24, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    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 · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF DEVICE HISTORY RECORDS: 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: REVISION DUE TO INFECTION. EVENT DESCRIPTION: - EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT HAD INITIALLY UNDERGONE A THA IN 2011 (ASSUMED DATE IS (B)(6) 2011), WHERE ALLOFIT CUP 60MM AND METASUL LINER WERE IMPLANTED. PATIENT UNDERWENT THE FIRST REVISION OF THE THA ON (B)(6) 2017 DUE TO UNKNOWN REASONS, WHERE THE LINER AND HEAD WERE REPLACED WITH DURASUL LINER (REF:01.00013.713 LOT:2838483) AND COCR HEAD (REF:01.01012.366 LOT:2879338). LATER ON, PATIENT HAD A WASH OUT SURGERY ON (B)(6) 2017 DUE TO UNKNOWN REASONS, WHERE THE PRODCUTS REMAINED IN-SITU. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2017 TO DUE TO INFECTION, WHERE THE LINER AND HEAD WERE REPLACED WITH DURASUL LINER (REF: 01.00013.713 LOT: 2835104) AND COCR 36MM HEAD (REF: 01.01012.366 LOT 2882093). THIS COMPLAINT COVERS THE EVENT OF 2ND REVISION DUE TO INFECTION ON (B)(6) 2017. (B)(4)- WASHOUT SURGERY ON (B)(6) 2017 (B)(4) 1ST REVISION DUE TO UNKNOWN REASONS ON (B)(6) 2017 REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WAS NOT AVAILABLE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. IT WAS REPORTED THAT THE DEVICES WERE DISCARDED. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - STERILIZATION CERTIFICATE (COCR HEAD) AND (DURASUL INSERT) WERE REVIEWED. THE STERILIZATION CERTIFICATES CONFIRM THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. ROOT CAUSE ANALYSIS AND CONCLUSION SUMMARY: ACCORDING TO THE REPORTED EVENT HEAD AND LINER OF THE THA WERE REVISED DUE TO THE INFECTION AFTER 1 MONTH IN-VIVO TIME. NO MEDICAL DOCUMENTS WERE RECEIVED CONFIRMING THE INFECTION. STERILIZATION SPECIFICATIONS OF THE DEVICES CERTIFY THE SUITABILITY OF STERILIZATION. STERILIZATION CERTIFICATES ARE REVIEWED. THE STERILIZATION CERTIFICATES CONFIRM THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. 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 IS NOT SUSPECTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO ANY PATIENT 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. POSSIBLE CAUSES INCLUDE CONTAMINATION OF THE PRODUCT DURING OP, DAMAGE OF THE PACKAGING DURING TRANSPORTATION AND REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE. OTHER COMPONENTS OF THE THA, EXCEPT THE HEAD AND LINER ARE NOT REPORTED. THEREFORE, THE STERILIZATION CERTIFICATES COULD NOT BE REVIEWED OF THOSE UNKNOWN PARTS. 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. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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). THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURAL ALPHA INSERT NEUTR GG/32) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DURASUL, ALPHA INSERT, MM/36 12/14 ON (B)(6) 2017 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717700 DURASUL, ALPHA INSERT, MM/36 UNKNOWN LPH ZIMMER GMBH N/A 2838483

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R