Study: NCT01936259

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 130 at risk

Adverse event: Death (Non-Shoulder Related)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 130 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 130 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 130 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 130 at risk

Adverse event: Other General (Non-Shoulder Related) Complication
Serious: yes
Organ System: General disorders
Frequency: 44 affected / 130 at risk

Adverse event: Dislocation / Subluxation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Implant or Part Failure or Fracture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 130 at risk

Adverse event: Other Shoulder-Related Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 130 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 130 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 130 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 130 at risk

Adverse event: Other General (Non-Shoulder Related) Complication
Serious: no
Organ System: General disorders
Frequency: 88 affected / 130 at risk

Adverse event: Dislocation / Subluxation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 130 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 130 at risk

Adverse event: Humeral Fracture or Perforation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 130 at risk

Adverse event: Implant or Part Failure or Fracture
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 130 at risk

Adverse event: Inadequate Range of Motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 130 at risk

Adverse event: Instability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Loosening or Migration of Implants or Parts
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 130 at risk

Adverse event: Unusual Shoulder Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 130 at risk

Adverse event: Wound Problems: Dehiscence, Necrosis, Drainage, Superficial Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Other Shoulder-Related Complication
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 130 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 131 at risk

Adverse event: Death (Non-Shoulder Related)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 131 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 131 at risk

Adverse event: Other General (Non-Shoulder Related) Complication
Serious: yes
Organ System: General disorders
Frequency: 35 affected / 131 at risk

Adverse event: Other Shoulder-Related Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 131 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 131 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 131 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 131 at risk

Adverse event: Other General (Non-Shoulder Related) Complication
Serious: no
Organ System: General disorders
Frequency: 72 affected / 131 at risk

Adverse event: Delayed Wound Healing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Dislocation / Subluxation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 131 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 131 at risk

Adverse event: Inadequate Range of Motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 131 at risk

Adverse event: Instability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 131 at risk

Adverse event: Nerve Deficit
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Unusual Shoulder Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 131 at risk

Adverse event: Wound Problems: Dehiscence, Necrosis, Drainage, Superficial Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 131 at risk

Adverse event: Other Shoulder-Related Complication
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 131 at risk