BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM EPOCH FEMORAL STEM

    MDR report key: 1960956 · Received January 11, 2011

    Report

    Report Number
    1822565-2011-00040
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    September 22, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. NO SURGICAL NOTES WERE RECEIVED, AND ONLY A BRIEF NOTE WAS RECEIVED FROM THE THA DONE IN 2007 WHICH IS MOSTLY ILLEGIBLE. IT IS UNK WHETHER THE STEM WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER SURGICAL TECHNIQUE. INSTRUMENTATION USED IS UNK. X-RAY IMAGES POST-PRIMARY SURGERY AND FROM THE REVISION SURGERY WERE NOT RETURNED. INFO REGARDING MATING COMPONENTS SUCH AS THE HEAD, LINER OR SHELL WAS NOT PROVIDED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, HEIGHT/WEIGHT, BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), REHABILITATION PROTOCOL BOTH PHYSIOLOGICAL AND PHARMACEUTICAL AND COMPLIANCE THEREOF ARE UNK. BASED ON THE ABOVE INFO, THE CAUSE OF THE PAIN THAT RESULTED IN THE REVISION SURGERY IS UNK. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM EPOCH FEMORAL STEM HIP PROSTHESIS LPH ZIMMER, INC. 60629379

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention