BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER HUMERAL STEMS

    MDR report key: 7295081 · Received February 24, 2018

    Report

    Report Number
    1818910-2018-54027
    Event Type
    Injury
    Date Received
    February 24, 2018
    Report Date
    February 9, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ARTICLE REVIEWED ENTITLED: "REVERSE SHOULDER ARTHROPLASTY: THE SINGAPORE GENERAL HOSPITAL EXPERIENCE AND A SIMPLE METHOD OF MEASURING CHANGE IN THE CENTER-OF-ROTATION" BY CHAY-YOU ANG, KAH-WENG LAI, ET AL IN JOURNAL OF ORTHOPAEDICS 12 (2015) 97-101, DESCRIBED A STUDY OF TEN PATIENTS, WHO RECEIVED DEPUY DELTA REVERSE SHOULDER ARTHROPLASTY, FOR PURPOSES OF DEVELOPING A TECHNIQUE TO MEASURE CHANGES IN CENTER OF ROTATION FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT ONE PATIENT, DESIGNATED AS PATIENT 9 IN THE STUDY, EXPERIENCED A POST-OPERATIVE COMPLICATION OF WRIST DROP ON THE OPERATIVE EXTREMITY, CAUSED BY TRACTION INJURY TO THE POSTERIOR CORD OF THE BRACHIAL PLEXUS OCCURRING DURING PROCEDURE. THERE WAS NO FOLLOW-UP REVISION SURGERY, BUT IT WAS REPORTED THAT IT REQUIRED A YEAR FOR THE WRIST DROP TO RESOLVE, AND THAT THE SHOULDER CONTINUED TO HAVE DECREASED MOBILITY. HUMERAL STEM COMPONENT WAS NOTED AS CEMENTED. CEMENT MANUFACTURER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137477 UNKNOWN SHOULDER HUMERAL STEMS SHOULDER HUMERAL STEMS HSD DEPUY FRANCE SAS - 3003895575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention