BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER

    MDR report key: 6821743 · Received August 25, 2017

    Report

    Report Number
    0001822565-2017-06055
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - UNKNOWN GLENOID HEAD # NI LOT # NI. UNKNOWN STEM 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 - 06054, 0001822565 - 2017 - 06052, 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 00434903611, GLENOSPHERE 36 MM DIAMETER, 62304086. THE 00434901500, BASE PLATE 15 MM, 62323920. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-06052-1, 0001822565-2017-06054-1, 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 WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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
    602470 POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER PROSTHESIS, SHOULDER KWT ZIMMER, INC. N/A 62232563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other