BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 2980512 · Received February 21, 2013

    Report

    Report Number
    1822565-2013-00357
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMORAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75114 ZIMMER M/L TAPER FEMORAL STEM LPH ZIMMER, INC. 60948108

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MANUFACTURED BY ZIMMER (B)(4)| LOT# 61648006,| VERSYS FEMORAL HAED: CATALOG # 00801803201,