BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SHELL

    MDR report key: 3893681 · Received June 10, 2014

    Report

    Report Number
    1822565-2014-00733
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER OPERATIVE NOTES NOR X-RAYS HAVE BEEN RETURNED FOR REVIEW. THE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNK. IN GENERAL, PT 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 AND ADHERENCE THERETO IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVAL: 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 SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, 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 WAS REVISED DUE TO LOOSENING, BROKEN SCREW AND A BROKEN CERAMIC CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340284 ZIMMER SHELL HIP PROSTHESIS LZO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention UNKNOWN ZIMMER SCREW: CATALOG # UNK, LOT# UNK