Zimmer Biomet Shoulder Arthroplasty PMCF

Ki vehet részt

• Patient must be 20 years of age or older
• Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants
• Patient is a candidate for shoulder arthroplasty due to one or more of the following:; Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate
• Patient must be able and willing to complete the protocol required follow-up
• Patient must be able and willing to sign the IRB/EC approved informed consent
• Patient has grossly deficient rotator, (for reverse application); With severe arthropathy and/or; Previously failed shoulder joint replacement
• Patient must have functional deltoid muscle (for reverse application)

Ki nem vehet részt

• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant)
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study
• Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site
• Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable
• Patient has a metabolic disorder that may impair bone formation
• Patient is unwilling or unable to give consent or to comply with the follow-up program
• Patient is known to be pregnant or breastfeeding
• Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
• Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device
• Patient has osteomalacia
• Patient has deficient rotator cuff
• Patient presents with significant injury to the upper brachial plexus
• Patient has paralysis of the axillary nerve
• Patient has non-functional deltoid or external rotator muscles