BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM PRESS-FIT

    MDR report key: 2100799 · Received May 19, 2011

    Report

    Report Number
    1822565-2011-01210
    Event Type
    Injury
    Date Received
    May 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE FEMORAL STEM HAS BEEN IN VIVO FOR APPROX (B)(6). SURGICAL NOTES WERE PROVIDED AND REVIEWED BUT DID NOT INDICATE ANY COMPLICATIONS. X-RAYS WERE NOT 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, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. THERE IS INSUFFICIENT INFO TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. THE MFG RECORDS OF THE (B)(4) TAPER STEM WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE STEM WAS MFG, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN IN RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER FEMORAL STEM PRESS-FIT LPH ZIMMER, INC. 60842447

    Patients

    Seq Age Sex Outcome Treatment
    1 Other