BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL REVERSE SHOULDER HUMERAL STEM

    MDR report key: 6070630 · Received November 1, 2016

    Report

    Report Number
    0001822565-2016-04027
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    PMA / PMN Number
    PK121543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPDATED WITH 510K NUMBER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES - CATALOG #01.04223.042, INVERSE/REVERSE SCREW SYSTEM, LOT #2797937; CATALOG #01.04223.036, INVERSE/REVERSE SCREW SYSTEM, LOT #2823876; CATALOG #00434904011, GLENOSPHERE 40MM DIAMETER, LOT# 63224442; CATALOG #00434901500, BASEPLATE 15MM POST LENGTH, LOT #63275346. NO DEVICES OR PHOTOS WERE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LINER AND THE STEM WITH NO DEVIATIONS OR ANOMALIES BEING IDENTIFIED. THIS DEVICE IS USED FOR TREATMENT. THE COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR THE DEVICES AND FOUND NO ADDITIONAL COMPLAINTS FOR THE SAME LOTS. SURGICAL TECHNIQUE AND NOTES WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1822565-2016-04027 AND 1822565-2016-04025).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S POLYETHYLENE COMPONENT DISASSOCIATED FROM THE HUMERAL STEM AND THAT THEIR SHOULDER PROSTHESIS DISLOCATED APPROXIMATELY FOUR MONTHS POST-IMPLANTATION. THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE TO TRY TO CORRECT THE DISLOCATION, BUT SUBSEQUENTLY REQUIRED REVISION TO REMOVE THE PROSTHESES, AS THE CLOSED REDUCTION WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO THE POLY DISSOCIATING FROM THE HUMERAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720118 TRABECULAR METAL REVERSE SHOULDER HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER, INC. 63202655

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R