BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 5517691 · Received March 22, 2016

    Report

    Report Number
    2648920-2016-00084
    Event Type
    Injury
    Date Received
    March 22, 2016
    Date of Event
    February 17, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    LPH
    PMA / PMN Number
    PREFER H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). OTHER DEVICES USED: CATALOG # (B)(4), TRILOGY LONGEVITY CROSSLINKED POLY LINER, LOT #61149077; CATALOG # (B)(4), ZIMMER M/L KINECTIV NECK, LOT #60969523 MANUFACTURED BY ZIMMER INC. (B)(6). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED. PHOTOGRAPHS OF THE EXPLANTED TAPER NECK SHOW SIGNS OF DISCOLORATION, WHICH IS INDICATIVE OF CORROSION. IT CANNOT BE DETERMINED IF THE EXPLANTED FEMORAL HEAD WAS SIMILARLY DISCOLORED. DHR REVIEW SHOWS NO DEVIATIONS TO THE STANDARD MANUFACTURING PROCESS. THESE DEVICES ARE USED FOR TREATMENT. OP NOTES CONFIRM THAT THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. THE ORIGINAL IMPLANT SURGERY FOR THE HIP CONSTRUCT WAS PERFORMED WITHOUT COMPLICATION. PATIENT IS BILATERAL WITH A LEFT THA IMPLANTED IN 2010. IT IS STATED IN PATIENT MEDICAL RECORDS THAT PATIENT FOLLOWED REHABILITATION PROTOCOL, HAD A MODERATE ACTIVITY LEVEL, AND IS NOTED TO HAVE FAIR BONE QUALITY. ON (B)(6) 2015, A FOLLOW UP BILATERAL HIP EXAM WAS PERFORMED. PATIENT HAD NO NEUROVASCULAR PROBLEMS, GAIT IRREGULARITIES, ISSUES WITH SENSATION, OR LEG LENGTH DISCREPANCIES. INTERNAL ROTATION IN FLEXION WAS NOTED TO BE SLIGHTLY IMPINGED. PATIENT WAS SUFFERING MODERATE PAIN AND TENDERNESS IN THE GREATER TROCHANTERIC REGION. A RIGHT HIP MRI REVEALED THAT A PSEUDOTUMOR HAD FORMED ALONG THE LATERAL AND POSTERIOR GREATER TROCHANTER. THE PSEUDOTUMOR WAS DETERMINED TO BE CONSISTENT WITH PARTICLE DISEASE. IN ADDITION, MRI REVEALED SEVERE CHRONIC PARTIAL TEARING OF THE GLUTEUS MINIMUS TENDON, AND SEVERE MUSCLE ATROPHY IN THE CONNECTING TISSUE. CHROMIUM ION LEVELS WERE DETERMINED TO BE APPROXIMATELY 2.1 UG/L. REVISION OPERATIVE NOTES COULD NOT BE OBTAINED. SURGEON HAS ALLEGED TAPER CORROSION OF THE DEVICES. BASED ON THE INFORMATION PRESENTED, IT IS LIKELY DEVICE CORROSION HAS LED TO THE ONSET OF PARTICLE DISEASE, HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4) LOT: 61192705 ( K953337); (B)(4), LOT: 60969523 ( K063251).

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT'S HEAD, LINER, AND NECK WERE ALL REVISED FOLLOWING SYMPTOMS OF PAIN AND CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174399 VERSYS FEMORAL HEAD LPH LPH ZIMMER, TURPEAUX INDUSTRIAL PARK 61192705

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention