BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER HUMERAL HEAD

    MDR report key: 11848770 · Received May 19, 2021

    Report

    Report Number
    0009613350-2021-00225
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    September 30, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSD
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL: H2, H6. CORRECTION: B4, G3, G6, H10. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON AN UNKNOWN DATE DUE TO DISLOCATION. REVIEW OF RECEIVED DATA: - THE SALES REPRESENTATIVE DID NOT CONFIRM THE CASE AND STATED THAT NO REVISION SURGERY WAS PERFORMED OR PLANNED. THEREFORE, NO MEDICAL DATA RELEVANT TO THE CASE HAVE BEEN RECEIVED. - DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: - THE DEVICES REMAIN IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: - DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATIONS. - DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATIONS. CONCLUSION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON AN UNKNOWN DATE DUE TO DISLOCATION. HOWEVER, BASED ON THE GIVEN INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND EXPERIENCED DISLOCATION. REVISION IS YET TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745493 ANATOMICAL SHOULDER HUMERAL HEAD ANATOMICAL SHOULDER HUMERAL HEAD HSD ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization