BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM REVISION FEMORAL STEM BEADED FULLCOAT PLUS

    MDR report key: 1070983 · Received July 3, 2008

    Report

    Report Number
    1822565-2008-00389
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE AND X-RAY ARE NOT PROVIDED FOR REVIEW. MATING DEVICE DETAILS ARE NOT AVAILABLE. PATIENT INFORMATION SUCH AS WEIGHT, ACTIVITY LEVEL, BUILD AND SEX ARE NOT AVAILABLE. NO ENGINEERING ANALYSIS CAN BE DONE WITH AVAILABLE INFORMATION. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007. POST-OP, PATIENT PRESENTED WITH PAIN AND X-RAY REVEALED STEM HAD FRACTURED APPROXIMATELY ONE YEAR AFTER IMPLANTATION. REVISION SURGERY IS PENDING. EXACT IMPLANT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM REVISION FEMORAL STEM BEADED FULLCOAT PLUS HIP PROSTHESIS KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK