BEUDAMED
    FDA Adverse Event Other Summary report: N

    AS HUMERAL HEAD FX LEFT 44

    MDR report key: 4934690 · Received July 21, 2015

    Report

    Report Number
    9613350-2015-00804
    Event Type
    Other
    Date Received
    July 21, 2015
    Date of Event
    July 4, 2015
    Report Date
    July 4, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF INCOMING INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WITH A SHOULDER STEM SIZE 10 AND HEAD 44. DEVICES WERE IMPLANTED ON (B)(6) 2015. PATIENT IS BEING MONITORED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. NO OTHER DOCUMENTS WERE PROVIDED. POSSIBLE CAUSES THE PRODUCTS RELATED TO THIS COMPLAINT WERE NOT RETURNED FOR INVESTIGATION. AS NO LOT NUMBERS AND SUPPLEMENTAL DOCUMENTATION (E.G. SURGICAL REPORTS, X-RAYS) WAS PROVIDED, NO PROPER ASSESSMENT OF THIS REPORTED EVENT COULD BE CONDUCTED. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN WITH A SHOULDER STEM SIZE 10 AND HEAD 44. DEVICES WERE IMPLANTED ON (B)(6) 2015. NO OTHER INFORMATION WAS AVAILABLE. PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE WITHIN THE RISK MANAGEMENT FILE. BASED ON THE GIVEN INFORMATION, A FINAL ASSESSMENT IS THEREFORE NOT POSSIBLE. HOWEVER, ALL POTENTIAL FAILURE MODES AND CAUSES ARE COVERED IN THE CORRESPONDING DFMEAS. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, WE WILL RE-EVALUATE THE CASE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A AS HUMERAL HEAD FX LEFT 44 ON THE LEFT SIDE ON (B)(6) 2015. CURRENTLY THE PATIENT IS BEING MONITORED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471764 AS HUMERAL HEAD FX LEFT 44 ANATOMICAL SHOULDER FRACTURE SYSTEM KWS ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other