BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER LOCKING SCREW

    MDR report key: 9281453 · Received November 5, 2019

    Report

    Report Number
    1818910-2019-114199
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    August 27, 2012
    Report Date
    October 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IN THE ARTICLE ENTITLED ¿REVISION OF REVERSED TOTAL SHOULDER ARTHROPLASTY. INDICATIONS AND OUTCOME.¿ WRITTEN BY MAZDA FARSHAD; MARION GROGLI; SABRINA CATANZARO; AND CHRISTIAN GERBER; WAS REVIEWED. THE ARTICLES PURPOSE WAS A RETROSPECTIVE STUDY TO IDENTIFY THE REASONS FOR REVISION OF REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) AND TO REPORT OUTCOMES. THE ARTICLE WAS BASED ON RTSA¿S PERFORMED WITH IMPLANTS OF THE: DELTA III (DEPUY) 232 IMPLANTED, AND A COMPETITOR, 248 IMPLANTED BETWEEN 1999-2008. 67 CASES NEEDED AT LEAST ONE ADDITIONAL INTERVENTION TO TREAT A COMPLICATION, 30 OF THEM NEEDED A SECOND, ELEVEN OF THEM A THIRD AND FOUR A FOURTH ADDITIONAL INTERVENTION. THE MOST COMMON COMPLICATION REQUIRING A FIRST INTERVENTION WAS INSTABILITY, FOLLOWED BY A HEMATOMA OR SUPERFICIAL WOUND COMPLICATIONS AND COMPLICATIONS OF THE GLENOID COMPONENT. PATIENTS BENEFITED FROM THE RTSA DESPITE THE NEED OF ADDITIONAL INTERVENTIONS AS INDICATED BY A MEAN INCREASE IN TOTAL CONSTANT-MURLEY SCORE FROM 23 POINTS BEFORE RTSA TO 46 POINTS AT FINAL FOLLOW-UP. COMPLICATIONS WERE AS FOLLOWS--ALL OF WHICH REQUIRED REVISIONS: INSTABILITY RESULTING IN SUBLUXATIONS OR DISLOCATION. FIVE WERE CLOSED REDUCTIONS, SEVEN REQUIRED A CHANGE OF COMPONENTS TO A SELECTION OF A HIGHER HUMERAL POLYETHYLENE INLAY WAS USED IN THREE, REVISION OF GLENOID COMPONENT IN TWO, AND REVISION OF A HUMERAL COMPONENT IN TWO CASES. EIGHT RESULTED IN HEMATOMAS WITH SIMPLE EVACUATION. THREE COMPLICATIONS OF GLENOID COMPONENT-ONE CHANGED GLENOID CONVERSION AND TWO COMPONENT WEAR. ONE FOR PAIN. TWO DEFICIENT IN EXTERNAL ROTATION. THREE FOR INFECTION. THREE FOR HUMERAL COMPONENT LOOSENING. TWO DISTURBING ORIF MATERIAL. TWO PERIPROSTHETIC FRACTURES. ONE DISLOCATION OF GREATER TUBEROSITY. ONE HETEROTOPIC OSSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071259 UNKNOWN SHOULDER LOCKING SCREW SHOULDER LOCKING SCREW HSD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention