BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, MM/36

    MDR report key: 6933814 · Received October 10, 2017

    Report

    Report Number
    0009613350-2017-01416
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 2, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO SPECIFIC EVENT INFORMATION WAS AVAILABLE. REVIEW OF EVENT DESCRIPTION: 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 PRODUCTS 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 WASHOUT SURGERY DUE TO UNKNWON REASONS ON (B)(6) 2017. THE FIRST REVISION SURGERY DUE TO UNKNOWN REASONS ON (B)(6) 2017 IS REPORTED IN (B)(4). THE SECOND REVISION SURGERY DUE TO INFECTION ON (B)(6) 2017 IS REPORTED IN (B)(4). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT BUT WAS NOT AVAILABLE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCTS WERE DISCARDED AFTER THE REVISION SURGERY REPORTED IN (B)(4). REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. STERILIZATION CERTIFICATES FOR COCR HEAD AND DURASUL INSERT WERE REVIEWED. THE STERILIZATION CERTIFICATES CONFIRM THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. ROOT CAUSE ANALYSIS: DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ROOT CAUSE ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, ALL POSSIBLE CAUSES THAT MIGHT BE LEADING TO THE ISSUES REPORTED ARE LISTED IN DFMEA FOR DURASUL INSERT AND COCR HEAD. CONCLUSION SUMMARY: ACCORDING TO THE REPORTED EVENT, THE PATIENT HAD A WASHOUT SURGERY DUE TO UNKNOWN REASONS AFTER 2 WEEKS POST-SURGERY. NO PRODUCTS WERE REVISED. NO MEDICAL DOCUMENTS WERE RECEIVED TO CONFIRM ANY EVENT. DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL INVESTIGATION OF THE REPORTED EVENT. THEREFORE, A POSSIBLE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE, THE CASE WILL BE RE-EVALUATED. 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. AS NO LOT NUMBER WAS PROVIDED, 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. 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 THE PATIENT WAS IMPLANTED ON (B)(6) 2017 WITH A DURASUL LINER AND COCR HEAD. PATIENT UNDERWENT A WASHOUT SURGERY ON (B)(6) 2017 BUT BOTH PRODUCTS REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713886 DURASUL, ALPHA INSERT, MM/36 LPH ZIMMER GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R