BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER BIGLIANI/FLATOW HUMERAL STEM

    MDR report key: 4240334 · Received October 30, 2014

    Report

    Report Number
    1822565-2014-01488
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED VIA PUBLISHED LITERATURE. EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO, HOWEVER, NO INFO HAS BEEN RECEIVED TO DATE. WITH THE SUPPLIED INFO AN EXACT CAUSE CANNOT BE DETERMINED AT THIS TIME. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS WERE UNAVAILABLE. 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 ADD'L 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 RADIOGRAPHIC EVAL REVEALED THE PT'S HUMERAL COMPONENT HAD LUCENT LINES OF 2MM OR MORE IN ZONES 1, 2, 5 AND 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695219 UNK ZIMMER BIGLIANI/FLATOW HUMERAL STEM SHOULDER PROSTHESIS KWS ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other