BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER

    MDR report key: 1013943 · Received March 14, 2008

    Report

    Report Number
    1822565-2008-00104
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    January 2, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG # 00999207545, ZMR HIP SYSTEM FEMORAL BODY REVISION TAPER, LOT# 63737600. EVALUATION SUMMARY: THE TAPER STEM HAS FRACTURED AT THE JUNCTION WITH THE CONE BODY. SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWS THAT THE FRACTURE HAS OCCURRED BY FATIGUE. THE PACKAGE INSERT CONTAINS STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PATIENT WEIGHT, EXCESSIVE PATIENT ACTIVITY, OR LACK OR PROXIMAL SUPPORT OF THE BODY ARE INVOLVED. NOT ALL OF THESE FACTORS ARE KNOWN FOR THE CASE. THERE IS NO DEFINITIVE INDICATION THAT DESIGN OR MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE OUTCOME DESCRIBED HERE. RISK MANAGEMENT ACTIVITY HAS BEEN INITIATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THIS REPORT WILL BE AMENDED. 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 DEVICES WERE IMPLANTED IN 1999. REVISION SURGERY OCCURRED IN 2008, DUE TO BREAKAGE. EXACT IMPLANT DATE IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R