BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6

    MDR report key: 15770488 · Received November 10, 2022

    Report

    Report Number
    3005180920-2022-00820
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 12, 2022
    Report Date
    November 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706001
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-OCT-2022. LOT 2009918: (B)(4). EXPIRATION DATE: 2026-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION PERFORMED AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO TUBEROSITIES RE-ABSORPTION, WHICH CAUSED PAIN AND LIMITED ROM. ACCORDING TO REPORT, DURING THE REVISION, MOBILIZATION OF THE STEM WAS DETECTED. ADDITIONALLY, IT SEEMS FROM THE RADIOGRAPHIC IMAGES THAT THE ANATOMICAL IMPLANT IS SMALLER THAN THE CANAL BONE. WE CANNOT TELL IF THIS IS THE RESULT OF POST-SURGERY HEALING PROCESS OF THE BONE, WHICH MAY RESULT IN BONE DIMENSIONAL CHANGES, OR THE SURGEON'S CHOICE: IN THE LATTER CASE, NO EXPLANATION FOR THIS DECISION WAS SUPPLIED.THEREFORE THE NEW IMPLANT WAS CHOSEN 2 SIZES BIGGER. THE ANATOMICAL IMPLANT WAS REVISED INTO A REVERSE IMPLANT WITH A LATERALIZED GLENOSPHERE. PRELIMINARY INVESTIGATION PERFORMED BY R&D: CASE OF TUBEROSITIES REABSORPTION IN A PATIENT WITH PREVIOUS PROXIMAL HUMERAL FRACTURE. DESPITE THE IMPLANT MOBILIZATION NOTICED DURING THE REVISION SURGERY, THE HUMERAL DIAPHYSIS SHOWS SIGNS OF OSSEOINTEGRATION ON THE COATED REGION. NO FURTHER COMMENTS CAN BE MADE BASED ON THE INFORMATION AT HAND. ADDITIONAL COMPONENTS INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0131 HC PEGGED GLENOID Ø46 (K170910) LOT 1908966: (B)(4). EXPIRATION DATE: 2025-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 (K170910) LOT 2001148: (B)(4). EXPIRATION DATE: 2025-06-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ANATOMICAL SHOULDER SYSTEM 04.01.0023 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 6 (K170910) LOT 1811225: (B)(4). EXPIRATION DATE: 2024-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO TUBEROSITIES RE-ABSORPTION, WHICH CAUSED PAIN AND LIMITED ROM IN THIS PATIENT WITH PREVIOUS PROXIMAL HUMERAL FRACTURE. DURING THE REVISION, MOBILIZATION OF THE STEM WAS DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY BY CONVERTING THE SYSTEM FROM ANATOMICAL TO REVERSE AND IMPLANTING A LATERALIZED GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513056 ANATOMICAL SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6 SHOULDER HUMERAL DIAPHYSIS CEMENTLESS PHX MEDACTA INTERNATIONAL SA 04.01.0001 2009918 07630040706001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention