BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITMORE, HIP STEM, UNCEMENTED, B/9, TAPER 12/14

    MDR report key: 7070118 · Received November 30, 2017

    Report

    Report Number
    0009613350-2017-01693
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071723
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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: WORN PACKAGING MATERIAL (WITHIN STERIL BARRIER). EVENT DESCRIPTION: IT WAS REPORTED THAT SOME MATERIAL DEBRIS, LIKE DEBRIS OF CUSHIONING MATERIAL, WERE FOUND IN THE STERILE PACKAGING DURING INCOMING INSPECTION IN (B)(6). REVIEW OF RECEIVED DATA: RECEIVED PICTURES CONFIRM SOME INDEFINITE MATERIAL DEBRIS IN THE STERILE PACKAGING. DEVICES ANALYSIS: VISUAL EXAMINATION OF THE RETURNED PRODUCT SHOWS THAT THE CUSHIONING PART IN THE INNER STERIL PACKAGE IS WORN. THEREFORE TWO VERY SMALL PARTICLES OF THIS WHITE CUSHIONING MATERIAL MOVED IN THE PACKAGE. REVIEW OF PRODUCT DOCUMENTATION: CLARIFICATION WITH A PACKAGING SME SHOWS THAT THE PACKAGING DESIGN HAS BEEN CHANGED IN THE MEANTIME. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA. LEACHABLE OR ABRASIVE PARTICLES FROM PACKAGING MATERIAL CONTAMINATE MEDICAL DEVICE AND GET IN BODY CONTACT (TISSUE, BONE, CIRCULATORY SYSTEM, ETC) DUE TO PRESELECTED STERIL BARRIER CONTACT MATERIALS ARE NOT BIOCOMPATIBLE INCLUDING PACKAGING AIDS. NOT POSSIBLE: SINCE THE CUSHIONING RESIDUES AT HAND ARE STERILE AND WERE NOT LOCATED IN THE INNER STERILE BAG. THEREFORE THEY WOULD NOT COME IN DIRECT BODY CONTACT. RESIDUES FROM SURFACE OF PACKAGING MATERIAL CONTAMINATE MEDICAL DEVICE AND GET IN BODY CONTACT (TISSUE, BONE, CIRCULATORY SYSTEM, ETC) DUE TO LACK OF PHYSICAL OR CHEMICAL CLEANLINESS OF STERILE BARRIER CONTACT MATERIAL(S). NOT POSSIBLE: SINCE THE CUSHIONING RESIDUES AT HAND ARE STERIL AND WERE NOT LOCATED IN THE INNER STERILE BAG. THEREFORE THEY WOULD NOT COME IN DIRECT BODY CONTACT. CONCLUSION SUMMARY: IT WAS REPORTED THAT SOME MATERIAL DEBRIS, LIKE DEBRIS OF CUSHIONING MATERIAL, WERE FOUND IN THE STERILE PACKAGING DURING INCOMING INSPECTION IN (B)(6). INVESTIGATION RESULTS SHOW THAT THE CUSHIONING PART IN THE INNER STERIL PACKAGE IS WORN. THEREFORE TWO VERY SMALL PARTICLES OF THIS WHITE CUSHIONING MATERIAL MOVED IN THE PACKAGE. THE COMPLAINT HISTORY FOR PACKAGING CONFIGURATION SHOWS THAT THIS IS A SINGLE CASE. THERE IS NO RISK TO THE PATIENT SINCE THE CUSHIONING RESIDUES ARE STERIL AND ARE NOT LOCATED IN THE INNER STERILE BAG. NO DIRECT BODY CONTACT WOULD BE EXPECTED. IT IS ASSUMED THAT A EXTRAORDINARY TRANSPORT AND/OR HANDLING ISSUE LED TO THE WORN PACKAGING MATERIAL. HOWEVER, THE PACKAGING DESIGN OF THIS PRODUCT FAMILY HAS BEEN CHANGED IN THE MEANTIME. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILE PACKAGING ISSUE OF FITMORE, HIP STEM, UNCEMENTED, B/9, TAPER 12/14. SOME MATERIAL DEBRIS, LIKE DEBRIS OF CUSHIONING MATERIAL WERE FOUND (CONFIRMED) IN THE STERILE PACKAGING. THE DEVICE WAS NOT USED. THE ISSUE WAS DETECTED IN THE WAREHOUSE IN (B)(6). NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS DAMAGED (STERILE PACKAGING ISSUE). HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850793 FITMORE, HIP STEM, UNCEMENTED, B/9, TAPER 12/14 FITMORE HIP STEM LZO ZIMMER GMBH N/A 2676086

    Patients

    Seq Age Sex Outcome Treatment
    1