BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER CONSTRUCT DELTA XTEND

    MDR report key: 22289629 · Received June 19, 2025

    Report

    Report Number
    1818910-2025-10119
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    March 3, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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. H11 ADDITIONAL NARRATIVE: ADDED: D4 (CATALOG).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CRONIN JT, CURTIS KB, RICHARDS BW, HIBBARD JN, SKEDROS JG. ACROMION AND CLAVICLE STRESS FRACTURES AFTER REVERSE TOTAL SHOULDER ARTHROPLASTY REFLECT FAILURE TO ADDRESS OSTEOPOROSIS: A CASE REPORT AND LITERATURE REVIEW. CUREUS. 2025 MAR 3;17(3):E79993. DOI: 10.7759/CUREUS.79993. PMID: 40041247; PMCID: PMC11876088. OBJECTIVE/METHODS/STUDY DATA: THIS CASE UNDERSCORES THE IMPORTANCE OF PRE-OPERATIVE BONE DENSITY/HEALTH SCREENING TO MITIGATE STRESS FRACTURE RISK AFTER RTSA. A 68-YEAR-OLD (155 CM TALL, 55 KG; BMI = 23) LEFT-HAND DOMINANT WOMAN PRESENTED WITH END-STAGE ROTATOR CUFF-TEAR ARTHROPATHY (FIGURE 1) THAT WAS TREATED WITH RTSA. THE PATIENT¿S RTSA WAS PERFORMED ON AUGUST 22, 2023, BY JGS. THE PROSTHESIS WAS A DEPUY DELTA XTEND® (DEPUY SYNTHES, WARSHAW, INDIANA, USA) AND INCLUDED THESE COMPONENTS: 10MM PRESS-FIT HUMERAL STEM WITH A NECK-SHAFT ANGLE OF 145° (WHERE 180° IS VERTICAL), 3MM-THICK POLYETHYLENE LINER, STANDARD GLENOID BASEPLATE, AND 38MM DIAMETER GLENOSPHERE WITH 2MM LATERAL OFFSET (FIGURE 3). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES DELTA XTEND. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT DELTA XTEND (QTY 1). ELEVEN WEEKS AFTER SURGERY, THE PATIENT NOTED NEW-ONSET LEFT SHOULDER PAIN LOCALIZED OVER THE BASILAR ACROMION REGION. RADIOGRAPHS SHOWED AN ANGULATED FRACTURE NEAR THE BASE OF THE ACROMION. AT 24 WEEKS AFTER SURGERY (FEBRUARY 7, 2024), THE PATIENT PRESENTED WITH COMPLAINTS OF ACUTE NEW-ONSET PAIN IN THE LEFT CLAVICLE REGION THAT BEGAN AFTER SHE ROLLED ONTO THAT SHOULDER WHILE SLEEPING. RADIOGRAPHS SHOWED A NON-DISPLACED MIDSHAFT CLAVICLE FRACTURE, IN ADDITION TO THE EXISTING ACROMION STRESS FRACTURE THAT SHOWED DELAYED HEALING (AND WAS ALSO PAINFUL TO PALPATION). THE NEW CLAVICLE FRACTURE OCCURRED IN THE VICINITY OF THE FRACTURE THAT HAD OCCURRED MANY YEARS PRIOR, WHICH LIKELY RESULTED IN COMPROMISED BONE DENSITY AS SUGGESTED BY FINDINGS. AT APPROXIMATELY 100 DAYS AFTER THE ACROMION FRACTURE, TREATMENT WITH A BONE-GROWTH STIMULATOR (EXOGEN®, BIOVENTUS LLC, DURHAM, NORTH CAROLINA, USA) WAS INITIATED. AT A FOLLOW-UP VISIT 28 WEEKS AFTER THE RTSA AND FOUR WEEKS AFTER THE CLAVICLE FRACTURE (MARCH 7, 2024), THE CLAVICLE FRACTURE WAS FOUND TO BE 100% DISPLACED. SHE DENIED ANY TRAUMA THAT MIGHT HAVE CAUSED THIS DISPLACEMENT AND DECLINED OUR RECOMMENDATION FOR SURGICAL RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865597 UNKNOWN SHOULDER CONSTRUCT DELTA XTEND SHOULDER CONSTRUCT KWS DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention