Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.
Patient who does not meet the inclusion criteria above
Patients who received the study devices implanted by the Investigator in accordance with the Indications for Use beginning January 1, 2018, through June 30, 2023.
Other
Retrospective
FX Artificial Shoulder Prosthesis
DeviceHumelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, PRCT II Fracture Plate, V-135
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
* Adjusted Constant Score \> 70 * No continuous radiolucency or device migration/subsidence * No revision surgery or removal * No serious device related adverse event The Study will continue to follow patients prospectively to 10 years postoperative to track survivorship.
Adjusted Constant Score
The Constant-Murley score (CMS) is a validated 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points) with the subject completing the assessment prior to the Investigator completing their part of the assessment. The higher the score, the higher the quality of the function. An Adjusted Constant score will be calculated using normalized values to account for age and gender, as based upon anatomical gender at birth.
QuickDASH
QuickDASH measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. The higher the score, the higher the function and lower pain in the patient.
American Shoulder and Elbow Surgeon (ASES)
ASES is a validated patient-reported outcome which is composed of 10 functional questions and one pain VAS. The total score is of 100 maximum points and weighted evenly between pain and function
Visual Analog Scale (VAS). A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length.
A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length.
Primary Effectiveness Endpoint
The primary safety endpoint is the occurrence of any serious, device-related adverse event through 24 months of follow-up defined as an onset date before or on 730 days following the index surgery. For the primary endpoint, device-related will be defined as definite, probable, or possible relationship to the device.
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