BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION, HEAD, S, 28/-3.0, TAPER 12/14

    MDR report key: 7333455 · Received March 13, 2018

    Report

    Report Number
    0009613350-2018-00350
    Event Type
    Injury
    Date Received
    March 13, 2018
    Report Date
    September 7, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK073567
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PAIN. REVIEW OF EVENT DESCRIPTION : IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY IS EXPERIENCING PAIN AND LEG LENGTH DISCREPANCY (LEG IS LONGER). LEFT LEG IS 2 CM LONGER THAN THE RIGHT LEG. REVIEW OF RECEIVED DATA: 9 X-RAYS HAVE BEEN RECEIVED. THE X-RAY ANALYSIS WAS PERFORMED BY AN INDEPENDENT RADIOLOGIST (HCP). THE X-RAY REVIEW STATES THE COMPONENTS OVERALL FIT AND ALIGNMENT IS APPROPRIATE. NORMAL BONE QUALITY. NO X-RAY EVIDENCE OF IMPLANT COMPONENT MALFUNCTION. NO SIGNS OF LOOSENING OR RADIOLUCENCY. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THE IMPLANTS REMAIN IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE. BASED ON THE GIVEN INFORMATION, A ROOT CAUSE ANALYSIS IS THEREFORE NOT POSSIBLE. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE, THE CASE WILL RE-EVALUATED. ALL POTENTIAL RISKS AND CAUSES REGARDING THE TWO PRODUCTS (STEM AND HEAD) ARE COVERED WITHIN THEIR CORRESPONDING RISK MANAGEMENT FILES (DFMEA AVENIR STEM AND RMW BIOLOX OPTION). CONCLUSION SUMMARY: BASED ON THE GIVEN INFORMATION AND THE RECEIVED X-RAYS WE WERE NOT ABLE TO RECREATE THE REPORTED EVENT CONSISTING OF PAIN AND LEG LENGTH DISCREPANCY. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FURTHERMORE, THE X-RAY ANALYSIS DID NOT REVEAL ANY VISIBLE HARDWARE FAILURE, MALFUNCTIONING OR LOOSENING OF THE IMPLANTED COMPONENTS. THE X-RAY ANALYSIS SUGGESTS AN APPROPRIATE OVERALL IMPLANT FIT AND ALIGNMENT AND NORMAL BONE QUALITY. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14, REF#: 01.06010.003 ; LOT#: 2863214. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00349. THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR INVESTIGATION AS THEY ARE STILL IN VIVO. SURGICAL REPORTS AND X-RAYS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4). ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY IS EXPERIENCING PAIN AND LEG LENGTH DISCREPANCY. LEFT LEG IS 2 CM LONGER THAN RIGHT LEG. IT WAS FURTHER REPORTED THAT THE PATIENT HAS PAIN AND WEARS A HEEL RAISE. IF THAT DOES NOT WORK THEN POSSIBLE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177683 BIOLOX OPTION, HEAD, S, 28/-3.0, TAPER 12/14 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM LZO ZIMMER GMBH N/A 2882592

    Patients

    Seq Age Sex Outcome Treatment
    1 Other