BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HYLAMER LINER

    MDR report key: 4111369 · Received September 23, 2014

    Report

    Report Number
    1818910-2014-28675
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE RETURNED PARTS AND LAB REPORT WERE TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED ((B)(4) REPORT) STATING: THE PARTS WERE IN-SITU FOR APPROXIMATELY 19 YEARS. BASED ON THE INFORMATION PROVIDED, NOTABLE OXIDATION WAS OBSERVED AS DISCOLOURATION ACROSS THE FRONT AND THE BACK SIDE OF THE LINER. DELAMINATION WAS ALSO OBSERVED ON THE BEARING SURFACE. NOTE, DAMAGE WAS NOTED ON THE LIP OF THE LINERS WHICH WAS ASSUMED TO BE DUE TO IMPINGEMENT BETWEEN STEM AND LINER. THIS IS AN UNUSUAL AREA FOR STEM IMPINGEMENT TO OCCUR (SEEMS TO BE SUPERIOR, AS OPPOSED TO INTERIOR) AND COULD HAVE ALSO BEEN DUE TO SEPARATIONS BETWEEN THE HEAD AND CUP. THIS COULD ALSO HAVE ACCELERATED THE WEAR OF THE INSERT. X-RAYS ARE REQUIRED TO ASSESS THE IMPLANT POSITION IN THE BODY. THE GAP BETWEEN THE HEAD AND THE LINER WAS ESTIMATED TO BE 5.5MM WIDE, SUGGESTING EROSION OF THE LINER. ALL OF THE ABOVE OBSERVATIONS WERE NOTED TO HAVE COLLECTIVELY CAUSED THE ELEVATED LEVELS OF WEAR OF THE HYLAMER LINER, WHICH COULD HAVE CONTRIBUTED TO THE ACETABULAR LYSIS NOTED BY THE SURGEON DURING SURGERY. GIVEN THE 19 YEARS OF SERVICE A SIGNIFICANT AMOUNT OF WEAR IS TO BE EXPECTED. THE MODE OF FAILURE OF THE PROSTHESIS IS MULTI-FACTORIAL AND CONSIDERATION HAS TO BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS, SURGICAL PROCESS, PATIENT VARIABLES I.E. ACTIVITY, WEIGHT, BMI AND USE, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. THIS REPORT DETAILS THE FINDINGS FROM A REVIEW OF THE EXPLANTS AND INFORMATION AS SUPPLIED AT THE TIME OF EVALUATION. ANY CONCLUSIONS FROM THIS DATA HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REVISION HIP AT (B)(6) PERFORMED ON (B)(6) 2014. THE REVISION WAS FOR PAIN. THE PATIENT HAS HAD HIS PREVIOUS SURGERY IN CHRISTCHURCH AND RECEIVED A PRODIGY STEM AND DURALOC 1200 SERIES CUP WITH A 28MM LIPPED HYLAMER LINER AROUND 1995. . THE PLAN WAS TO REVISE THE LINER ONLY BUT DUE TO SIGNIFICANT LYSIS, NOT VISIBLE ON AP FILM BEHIND THE CUP, THE SURGEON CHOSE TO REMOVE THE CUP, BONE GRAFT THE DEFECT, AND IMPLANT A PINNACLE GRIPTION MULTIHOLE WITH A 32MM LIPPED MARATHON LINER. 3 SCREWS WERE ALSO USED TO OFFER SECONDARY STABILITY. THE SURGEON THEN IMPLANTED A 32MM +9 DELTA TS CERAMIC REVISION HEAD, 1200 SERIES CUP CODE 1245-58, LOT T BIV-08, HYLAMER LINER CODE DD 28L 58, LOT 516030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589577 UNKNOWN HYLAMER LINER HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention