FX Shoulder Solutions Retrospective / Prospective Clinical Study

• 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.

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 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.

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

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.

ROM - The patient performs active movements in all functional planes for the shoulder.

Includes flexion, extension, abduction, adduction and internal and external rotation. Investigator estimates the range of movement and compares the affected with the unaffected shoulder and the normal expected range.

SSI's are re-operations, revisions, and removals.

An adverse event that is related to the use of a device.

• Led to a death,
• Resulted in life threatening illness or injury*
• Resulted in patient hospitalization or prolongation of existing hospitalization,
• Resulted in patient disability or permanent damage or required intervention to prevent permanent impairment/damage
• Led to a congenital abnormality or birth defect

Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

Monitor implant integrity and signs of implant loosening

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.