BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASULÂ, ALPHA INSERT, II/32

    MDR report key: 6971159 · Received October 24, 2017

    Report

    Report Number
    0009613350-2017-01487
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 26, 2017
    Report Date
    March 28, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK013935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ITEM: ALLOFIT ALLOCLASSIC SHELL 52/I I CATALOG #: 4245 LOT #: 2882155. ITEM: AVENIR MUELLER, STEM, LATERAL, UNCEMENTED, HA, 4, CATALOG #: 01.06010.104 LOT #: 4024135. INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: 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: INFECTION. EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A ZIMMER BIOMET HIP SYSTEM ON (B)(6) 2017 IN THE LEFT HIP. THE PATIENT EXPERIENCED INFECTION AND UNDERWENT REVISION SURGERY OF THE HEAD AND LINER ON (B)(6) 2017. PATIENT HAD PREVIOUS LEFT HIP WASHOUTS WITHOUT REMOVING IMPLANTS PREVIOUS WEEK. SHELL LINER TRIAL AND FEMORAL HEAD TRIAL WERE INSERTED ON (B)(6) 2017. ON (B)(6) 2017 PATIENT RETURNED FOR ANOTHER WASHOUT. TRIAL LINER AND HEAD WERE REMOVED. DEFINITIVE LINER AND HEAD INSERTED. WOUND CLOSURE WITH DRAINS. NO OTHER INFECTION ISSUE WITH RIGHT HIP REPLACEMENT. REVIEW OF RECEIVED DATA: 1 UNDATED AP VIEW PELVIS X-RAY IS AVAILABLE. NO OBVIOUS OBSERVATIONS REGARDING AN INFECTION EVENT. POSITIONS OF THE COMPONENTS ARE WITHOUT ANY PROBLEMS FOR THE LEFT THA. X-RAY WAS NOT SENT FOR REVIEW SINCE DATE IS NOT AVAILABLE AND AN X-RAY REVIEW WOULD NOT AID IN FINDING ROOT CAUSE FOR INFECTION. IMPLANT STICKERS WERE RECEIVED FOR BOTH PRIMARY NAD REVISION SURGERIES. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. IT WAS REPORTED THAT DEVICES WERE DISCARDED. REVIEW OF PRODUCT DOCUMENTATION: STERILIZATION CERTIFICATES WERE REVIEWED. THE STERILIZATION CERTIFICATES CONFIRM THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. CONCLUSION SUMMARY: ACCORDING TO THE REPORTED EVENT HEAD AND LINER OF THE THA WERE REVISED DUE TO THE INFECTION AFTER 20 DAYS 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 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. POSSIBLE CAUSES FOR INFECTION INCLUDE CONTAMINATION OF THE PRODUCT DURING OP, WRONG RESTERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS AND REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE. 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. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DURASULÂ, ALPHA INSERT, II/32 ON THE LEFT SIDE ON (B)(6) 2017 AND THE PATIENT UNDERWENT REVISION SURGERY (B)(6) 2017 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751115 DURASULÂ, ALPHA INSERT, II/32 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS LZO ZIMMER GMBH N/A 2845918

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R