BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    MDR report key: 2172653 · Received July 20, 2011

    Report

    Report Number
    1822565-2011-01666
    Event Type
    Injury
    Date Received
    July 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE STEM AND NECK COMBINATION CAN BE VERIFIED. THE NECK, HEAD AND LINER COMBINATION, HOWEVER, IS NOT KNOWN AND HENCE THE PRODUCT COMPATIBILITY CANNOT BE CHECKED. NO SURGICAL NOTES AN/OR INTRAOPERATIVE REPORTS ARE PROVIDED. IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHAB PROTOCOL IS UNK. RETURNED X-RAYS SHOW THE NECK DISSOCIATED FROM THE STEM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 PT WAS ADMITTED FOR PULMONARY EMBOLISM FOR REVIEW AND X-RAYS WERE ORDERED DUE TO NEW ONSET GROIN PAIN. IT WAS THEN DISCOVERED THAT THE HIP WAS DISLOCATED AND DISASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER MODULAR FEMORAL STEM MEH ZIMMER, INC. 61632101

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other CATALOG #00784800300, LOT #61308781| KINECTIV TECHNOLOGY MODULAR FEMORAL NECK: