BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER LOCKING SCREW

    MDR report key: 7377292 · Received March 28, 2018

    Report

    Report Number
    1818910-2018-56281
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 13, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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

    REVIEWED ARTICLE ENTITLED "LONG TERM FUNCTIONAL OUTCOME FOLLOWING REVERSE SHOULDER ARTHROPLASTY IN THE ELDERLY", BY J. F. CAZENEUVE, ET AL., PUBLISHED IN ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2011) 97, 583-589. A RETROSPECTIVE STUDY OF 35 CASES, PATIENTS WITH DEPUY DELTA III REVERSE SHOULDER PROSTHESES, FOR TREATMENT OF PROXIMAL HUMERUS FRACTURE, OF WHICH THE AUTHORS INDICATED CEMENTING OF THE HUMERAL COMPONENT. (THE MANUFACTURER OF THE CEMENT WAS NOT REPORTED; THE DEPUY CEMENTED HUMERAL STEM IS A MONOBLOC COMPONENT). A TOTAL OF EIGHT COMPLICATIONS OCCURRED IN EIGHT PATIENTS (23%): TWO CASES OF COMPLEX REGIONAL PAIN SYNDROME TYPE I (FORMELY REFLEX SYMPATHETIC DYSTROPHY SYNDROME) WHICH RESOLVED AFTER MEDICAL TREATMENT WITHIN SIX AND NINE MONTHS RESPECTIVELY; SIX REOPERATIONS (17%): A SURGICAL DRAINAGE FOR DEEP ACINETOBACTER INFECTION AT 21 DAYS IN ONE PATIENT WHO DID NOT REQUIRED PROSTHETIC REPLACEMENT, THREE CASES OF ADDITIONAL EXCISIONS OF THE TUBERCLE REMNANTS DUE TO A CAM EFFECT RESPONSIBLE FOR SUPERIOR DISLOCATIONS THUS RESULTING IN GOOD LONG-TERM STABILITY, REORIENTATION OF THE HUMERAL STEM AT 20¿ OF RETROVERSION IN ONE PATIENT FOR ANTERIOR DISLOCATION AT 28 POSTOPERATIVE DAYS INDUCED BY THE INTITIAL VOLUNTARY 10¿ ANTEVERSION OF THE HUMERAL STEM WHICH AIMED AT ACHIEVING BETTER INTERNAL ROTATION, AND ONE CASE OF ASEPTIC LOOSENING OF THE METAGLENE AT 12-YEAR FOLLOWUP ASSOCIATED WITH BREAKAGE OF THE INFERIOR FIXATION SCREW WHICH REQUIRED REPLACEMENT OF THE GLENOID COMPONENT AND CONVERSION TO A STANDARD IMPLANT SINCE A SUFFICIENT BONE STOCK WAS AVAILABLE, WITH NO ASSOCIATED REPLACEMENT OF THE HUMERAL STEM. ONLY MINOR WEAR OF THE POLYETHYLENE COMPONENT WAS OBSERVED. EACH COMPLICATION WILL BE ADDRESSED IN A SEPARATE COMPLAINT. THIS COMPLAINT WILL ADDRESS THE CASE OF ASEPTIC LOOSENING OF THE METAGLENE AT 12-YEAR FOLLOWUP ASSOCIATED WITH BREAKAGE OF THE INFERIOR FIXATION SCREW--WHICH REQUIRED REPLACEMENT OF THE GLENOID COMPONENT AND CONVERSION TO A STANDARD IMPLANT SINCE SUFFICIENT BONE STOCK WAS AVAILABLE, WITH NO ASSOCIATED REPLACEMENT OF THE HUMERAL STEM. ONLY MINOR WEAR OF THE ORIGINAL (12 YEAR OLD) POLYETHYLENE COMPONENT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220937 UNKNOWN SHOULDER LOCKING SCREW SHOULDER LOCKING SCREW KWS DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention