BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE 36 MM DIAMETER

    MDR report key: 6821742 · Received August 25, 2017

    Report

    Report Number
    0001822565-2017-06054
    Event Type
    Injury
    Date Received
    August 25, 2017
    Report Date
    November 16, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK130661
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN STEM # NI LOT # NI, UNKNOWN HUMERAL LINER CATALOG # NI LOT # NI, UNKNOWN TM BASE PLATE CATALOG # NI LOT # NI. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPOTS WERE FILLED FOR THIS EVENT: 0001822565 - 2017 - 06052, 0001822565 - 2017 - 06055, 0001822565 - 2017 - 06056.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: 00434901213, HUMERAL STEM, 62316674. THE 00434903600, POLY LINER, 62232563. THE 00434901500, BASE PLATE 15 MM, 62323920. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-06052-1, 0001822565-2017-06055-1, 0001822565-2017-06056-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. DEVICE WAS IDENTIFIED OF BEING IN SCOPE OF A PREVIOUS CORRECTION IN 2013. DEVICE WAS IMPLANTED PRIOR TO THE CORRECTION. HOWEVER, NO INFORMATION WAS ABLE TO BE OBTAINED TO DETERMINE IF THE REPORTED ISSUE IS RELATED TO THE CORRECTION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL REVERSE SHOULDER PROCEDURE AND IS EXPERIENCING TINGLING, PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602469 GLENOSPHERE 36 MM DIAMETER PROSTHESIS, SHOULDER KWT ZIMMER, INC. N/A 62304086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other