BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 3192017 · Received June 20, 2013

    Report

    Report Number
    1822565-2013-00999
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRIMARY THA OPERATIVE NOTES ARE RETURNED WHICH WERE NOT VERY DETAILED. HOWEVER, THEY GIVE NO INDICATIONS THAT THE SURGICAL TECHNIQUE WAS NOT FOLLOWED. THE COMPONENTS ARE CONFIRMED AS BEING COMPATIBLE. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) , AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281799 ZIMMER M/L TAPER FEMORAL STEM LZO ZIMMER, INC. 61690458

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CAT #00875705401, LOT #61666487| CONTINUUM TM SHELL WITH CLUSTER HOLES:| LOT #2568964M MFG BY ZIMMER (B)(4)| BIOLOX DELTA HEAD: CAT #00877503602