BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER HIP

    MDR report key: 3192007 · Received June 20, 2013

    Report

    Report Number
    1822565-2013-01003
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: EXACT IMPLANT DATES HAVE NOT BEEN PROVIDED, HOWEVER, X-RAYS WERE REC'D IN WHICH THA IS FIRST SEEN ON (B)(6) 2008. IT APPEARS THAT A ML TAPER WITH KINECTIV STEM/NECK HAS BEEN UTILIZED ON THE FEMORAL SIDE. COMPONENT PLACEMENT LOOKS ACCEPTABLE. X-RAYS DATED (B)(6) 2013 SHOW A DEFINITE SHADOW ON THE ACETABULAR COMPONENT. NO SURGICAL NOTES OR OFFICE VISIT NOTES HAVE BEEN PROVIDED. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) , AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING RIGHT HIP PAIN AND LACK OF BONE IN-GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281246 UNK ZIMMER HIP HIP PROSTHESIS LZO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other