BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER LOCKING SCREW

    MDR report key: 19593582 · Received June 24, 2024

    Report

    Report Number
    1818910-2024-13661
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    November 1, 2023
    Report Date
    June 24, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: FISCHER J, WELTER J, HORN N, GRABER S, PAPE HC, JABERG L, HESS F. IS MALUNION OF THE GREATER TUBEROSITY AFTER REVERSE SHOULDER ARTHROPLASTY IN PATIENTS WITH COMPLEX PROXIMAL HUMERUS FRACTURE ASSOCIATED WITH WORSE CLINICAL OUTCOMES? A PROSPECTIVE COHORT STUDY. ARCH ORTHOP TRAUMA SURG. 2023 NOV;143(11):6527-6533. DOI: 10.1007/S00402-023-04951-6. EPUB 2023 JUN 30. PMID: 37391524. OBJECTIVE/METHODS/STUDY DATA: PURPOSE TO ASSESS PATIENT OUTCOMES FOLLOWING REVERSE SHOULDER ARTHROPLASTY IN PATIENTS WITH COMPLEX PROXIMAL HUMERUS FRACTURE AND THE CLINICAL IMPLICATIONS OF GREATER TUBEROSITY (GT) MALUNIONS. METHODS THIS PROSPECTIVE STUDY INCLUDED 56 PATIENTS WHO UNDERWENT RSA (DELTA XTEND) TO TREAT PROXIMAL HUMERUS FRACTURES. WE USED A STANDARDIZED SUTURE TECHNIQUE TO REATTACH THE TUBEROSITIES. DEMOGRAPHIC, COMORBIDITY, AND RADIOLOGICAL PARAMETERS WERE COLLECTED. ASSESSMENTS AT 2-YEAR FOLLOW-UP (N =49) ARE GIVEN AS FOLLOWS: RANGE OF MOTION (ROM), PAIN LEVEL, CONSTANT MURLEY SCORES (CS), SUBJECTIVE SHOULDER VALUE (SSV), AND TUBEROSITY HEALING. RESULTS ANATOMIC TUBEROSITY HEALING WAS ACHIEVED IN 31 (55%) PATIENTS (GROUP 1), 14 (25%) HAD A MALUNION (GROUP 2), AND COMPLETE MIGRATION OCCURRED IN 11 (20%) (GROUP 3). NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN GROUPS 1 AND 2 WERE DETECTED: CS (P=0.53), SSV (P=0.07), ROM (FORWARD FEXION (FF) P=0.19, INTERNAL ROTATION (IR) P=0.34, AND EXTERNAL ROTATION (ER) P=0.76). GROUP 3 HAD POORER OUTCOMES (MEDIAN [IQR]) THAN GROUP 1: CS (59 [50¿71]) VS. 72 [65¿78]), FF (120 [100¿150]) VS. 150 [125¿160] AND ER (- 20 [- 20 TO 10] VS. 30 [20¿45], RESPECTIVELY. THREE COMPLICATIONS (GROUP 1) OCCURRED: ONE-STAGE REVISION AFTER LOW-GRADE INFECTION, HEMATOMA DUE TO EARLY RIVAROXABAN (ANTICOAGULANT DRUG) INTAKE, AND OPEN REDUCTION AND INTERNAL FIXATION FOR ACROMION INSUFFICIENCY FRACTURE. NO PATIENTS SHOWED SIGNS OF STEM OR GLENOID LOOSENING AFTER 2 YEARS. CONCLUSION CASES WITH COMPLETE SUPERIOR MIGRATION EXPERIENCED POORER CLINICAL OUTCOMES THAN THOSE WITH ANATOMIC HEALING. DESPITE A RELATIVELY HIGH MALUNION RATE, THE OUTCOMES WERE NOT SIGNIFICANTLY WORSE IN THESE PATIENTS COMPARED TO ANATOMICALLY HEALED GT CASES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK SHOULDER HUMERAL STEM DELTA XTEND, UNK SHOULDER HUMERAL CUP DELTA XTEND, UNK SHOULDER GLENOSPHERE DELTA XTEND, UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND, UNK SHOULDER METAGLENE, UNK SHOULDER LOCKING SCREW (MINIMUM OF 2) OTHER CONCOMITANT DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: TUBEROSITIES WERE REATTACHED WITH FIVE FORCEFIBER (STRYKER) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL STEM DELTA XTEND, UNK SHOULDER HUMERAL CUP DELTA XTEND, UNK SHOULDER GLENOSPHERE DELTA XTEND, UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND, UNK SHOULDER METAGLENE, UNK SHOULDER LOCKING SCREW (MINIMUM OF 2): QTY 1 LOW GRADE INFECTION TREATED WITH REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604196 UNKNOWN SHOULDER LOCKING SCREW SHOULDER LOCKING SCREW LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK SHOULDER GLENOSPHERE DELTA XTEND| UNK SHOULDER HUMERAL CUP DELTA XTEND| UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND| UNK SHOULDER HUMERAL STEM DELTA XTEND| UNKNOWN SHOULDER LOCKING SCREW| UNKNOWN SHOULDER METAGLENE