BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX DELTA HEAD, 12/14, 36 X 0

    MDR report key: 3593375 · Received January 3, 2014

    Report

    Report Number
    9613350-2013-02301
    Event Type
    Other
    Date Received
    January 3, 2014
    Date of Event
    December 10, 2013
    Report Date
    December 10, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE REVIEW OF THE ADDITIONAL INFORMATION RECEIVED ON JUNE 22, 2016 THE RESULTS OF THE INVESTIGATION ARE INCLUDED IN THIS REPORT. THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN RIGHT HIP THA. HE HAS HAD ISSUES WITH THE IMPLANTS ON BOTH THE LEFT AND RIGHT SIDE SINCE THE INITIAL PROCEDURES. HE WAS HAVING PAIN, STINGING, BURNING FEELINGS IN THE HIP CUP AREA. HE IS VERY UNCOMFORTABLE WHEN STANDING AND SITTING FOR ONE HOUR OR MORE SO HE KEEPS MOVING. HE ALSO HAS INFLAMMATION AND SWELLING ALONG WITH A CLUMSY FEELING IN HIS LEGS AND SENSITIVITY TO COLD. BIOLOX HEAD HAS BEEN IMPLANTED ALONG WITH CONTINUUM HIP SYSTEM. THERE IS ANOTHER BIOLOX HEAD IMPLANTED IN THE LEFT HIP. REVIEW OF RECEIVED DATA: X-RAY ANALYSIS : PRESURGICAL (1.4.2009): BOTH, LEFT AND RIGHT HIP CLEARLY INDICATE OSTEOARTHROSIS. POSTSURGICAL (30.06.2011/13.10.2013): WELL SEATED ACETABULAR AND FEMORAL COMPONENTS, CUP INCLINATION ANGLE IS WITHIN LIMITS. BIOLOX HEAD WELL PLACED IN CUP AND ON STEM TAPER. THE PATIENT HAD THA DUE TO PROGRESSIVE LOSS OF MOTION AND INCREASING PAIN DUE TO OSTEOARTHRITIS. THE SURGICAL REPORT DOES NOT MENTION ANY COMPLICATIONS OR PROBLEMS DURING THE IMPLANTATION. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET 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. 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. ZIMMER (B)(4) CONSIDER THIS CASE AS CLOSED. THIS IS A SPLIT COMPLAINT WITH ZIMMER INC. (B)(4) FOR THE CONTINUUM HIP SYSTEM LEFT SIDE WAS REPORTED UNDER (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS. OTHER SOURCE DOCUMENTS (OPERATIVE REPORT) FOR REVIEW AS THE PT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THIS IS A BILATERAL PT. LEFT HIP CASE IS REPORTED UNDER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REC'D A BIOLOX DELTA HEAD 12/14 36 X 0 ON THE RIGHT SIDE ON (B)(6) 2010. THE PT IS CURRENTLY BEING MONITORED DUE TO PAIN AND LIMPING. NO OTHER INFO WAS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4835 BIOLOX DELTA HEAD, 12/14, 36 X 0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH 2559374

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other