BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TM HUMERAL STEM

    MDR report key: 5083700 · Received September 17, 2015

    Report

    Report Number
    1822565-2015-01874
    Event Type
    Injury
    Date Received
    September 17, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/24076000. (B)(4). OPERATIVE NOTES WERE REQUESTED HOWEVER NONE PROVIDED. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. THE PART AND LOT NUMBERS OF THE PRODUCT ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE PRODUCT WAS USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THIS PRODUCT COULD NOT BE REVIEWED DUE TO THE LACK OF LOT NUMBERS. IT COULD NOT BE CONFIRMED IF THE DEVICES USED ARE AN APPROVED AND COMPATIBLE COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 1 PATIENT EXPERIENCED ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616480 UNKNOWN TM HUMERAL STEM SHOULDER PROTHESIS KWR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other