Anatomical Shoulder™ Fracture PMCF Study

This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.

All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.

Inclusion criteria

• Age - 18 years minimum.
• Sex - male and female.
• General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
• Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
• Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.

Exclusion criteria

• Patient is skeletally immature.
• Patient is pregnant.
• Patient is unwilling or unable to cooperate in a follow-up program.
• Patient is planned for a bilateral shoulder replacement.
• Patient shows one or more of the following medical conditions:

• Pathological Fracture
• Active Infection
• Patient requires one or more of the following medical interventions:

• Revision surgery (non-union)
• Inverse fracture prosthesis