BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSS HXL LINER STANDARD. +3S

    MDR report key: 18029489 · Received October 30, 2023

    Report

    Report Number
    3002788818-2023-00090
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    October 10, 2023
    Report Date
    December 5, 2023
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    PHX
    PMA / PMN Number
    K213827
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, BASED ON THE INFORMATION PROVIDED, DUE TO THE PATIENT'S NON-COMPLIANCE THE JOINT WAS DISLOCATED. ACCORDING TO THE REPORT, THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY AND THE LINER WAS EXCHANGED TO A SMITH AND NEPHEW'S RETENTIVE LINER. SINCE THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN, THE IMPACT TO THE PATIENT BEYOND THE REPORTED JOINT DISLOCATION AND SUBSEQUENT REVISION CANNOT BE CONFIRMED BASED ON THE LIMITED INFORMATION PROVIDED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TITAN TOTAL SHOULDER SYSTEM REVEALED THAT TOTAL SHOULDER ARTHROPLASTY OR HEMIARTHROPLASTY IS INDICATED FOR DISLOCATIONS. ALSO, ACCORDING TO WARNINGS, EXCESSIVE PATIENT WEIGHT, HIGH LEVELS OF PATIENT ACTIVITY, LIKELIHOOD OF FALLS, POOR BONE STOCK, METABOLIC DISORDERS AND DISABILITIES OF OTHER JOINTS MAY INCREASE THE RISK OF AFFECTING SHOULDER REPLACEMENT AND JEOPARDIZING THE EFFICACY OF THE IMPLANT, SURGICAL INTERVENTION MAY BE REQUIRED TO TREAT ADVERSE EFFECTS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE TRAUMATIC INJURY, PATIENT ANATOMY, POSTOPERATIVE CARE OR ABNORMAL LOADING OF LIMB. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A REVERSE TOTAL SHOULDER REPLACEMENT WAS PERFORMED ON (B)(6) 2023, DUE TO THE PATIENT'S NON-COMPLIANCE, THE JOINT WAS DISLOCATED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO TREAT THIS ADVERSE EVENT IN WHICH A RSS HXL LINER STANDARD. +3S WAS EXCHANGED TO A SMITH AND NEPHEW'S RETENTIVE LINER. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008620 RSS HXL LINER STANDARD. +3S SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ASCENSION ORTHOPEDICS, INC. 210756GE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention| O| H