BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SHOULDER HUMERAL HEAD CTA/CAP

    MDR report key: 14776085 · Received June 22, 2022

    Report

    Report Number
    1818910-2022-11480
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    February 27, 2022
    Report Date
    June 22, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TØTTRUP M, THILLEMANN JK, THILLEMANN TM, MECHLENBURG I, KLEBE T, SØBALLE K, STILLING M. EARLY OFFSET-INCREASING MIGRATION PREDICTS LATER REVISION FOR HUMERAL HEAD RESURFACING IMPLANTS. A RANDOMIZED CONTROLLED RADIOSTEREOMETRY TRIAL WITH 10-YEAR CLINICAL FOLLOW-UP. J ORTHOP RES. 2022 FEB 27. DOI: 10.1002/JOR.25298. EPUB AHEAD OF PRINT. PMID: 35220595. OBJECTIVE AND METHODS: THE SPECIFIC AIMS OF THIS LONG-TERM FOLLOW-UP STUDY WERE CONTRAST THE MEDIUM TO LONG-TERM OUTCOMES OF THE DEPUY GLOBAL CAP SHOULDER HEMIARTHROPLASTY WITH A COMPETITOR SHOULDER CONSTRUCT (1) TO COMPARE IMPLANT MIGRATION AT 5-YEAR FOLLOW-UP, (2) TO COMPARE CLINICAL OUTCOMES AT 5 YEARS AND AT 9¿13 YEARS FOLLOW-UP AND (3) TO EVALUATE IF IMPLANT MIGRATION, CHANGES IN OFFSET AND CHANGES IN HUMERAL HEAD INCLINATION WERE RELATED TO INCREASED RISK OF IMPLANT REVISION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: GLOBAL CAP HEMIARTHROPLASTY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: 13 MIGRATIONS IDENTIFIED RADIOGRAPHICALLY. AN UNKNOWN NUMBER OF THESE WERE REVISED. 7 REVISIONS OF THE GLOBAL CAP AND 8 REVISIONS OF THE COMPETITOR DEVICE. THE AUTHORS DO NOT PROVIDE THE REASONS FOR REVISION SPECIFIC TO EACH DEVICE MANUFACTURER. THE ACTUAL NUMBER OF DEPUY DEVICES ASSOCIATED WITH EACH EVENT IS UNKNOWN. REASONS FOR REVISIONS: GLENOID WEAR (CAPTURED AS BONE INJURY AS THE GLENOID WAS NOT RESURFACED), DEVICE MIGRATION, PAIN, PERIPROSTHETIC FRACTURE, ROTATOR CUFF TEAR, ANTERIOR SUBLUXATION (CAPTURED AS JOINT INSTABILITY), ONE INTRAOPERATIVE FINDING OF INADEQUATE OSSEOINTEGRATION WITHOUT LOOSENING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624447 UNK SHOULDER HUMERAL HEAD CTA/CAP SHOULDER HUMERAL HEAD HSD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown