Study: NCT03594071

Adverse event: Abcess of shoulder
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to device
Frequency: 1 affected / 294 at risk

Adverse event: Biceps tear/tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Biceps tear/tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Possibly related to device
Frequency: 2 affected / 294 at risk

Adverse event: Biceps tear/tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Related to device
Frequency: 1 affected / 294 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Graves disease
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Hip pain
Serious: yes
Organ System: General disorders
Notes: Related to device
Frequency: 1 affected / 294 at risk

Adverse event: Hip pain
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Incomplete healing
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Knee Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Labral tear
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Recurrent rotator cuff tear
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Removal of screw
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Rotator cuff and slap lesion repair
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Shoulder Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Spinal cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Arm pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Clicking/popping sensation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 7 affected / 294 at risk

Adverse event: Clicking/popping sensation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 4 affected / 294 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Discoloration of foot
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Erythema/rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Groin pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 3 affected / 294 at risk

Adverse event: Groin pain
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 294 at risk

Adverse event: Groin stiffness/tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Hip pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 19 affected / 294 at risk

Adverse event: Hip pain
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 2 affected / 294 at risk

Adverse event: Hip stiffness/tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Implant pulled out of bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to device
Frequency: 1 affected / 294 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 8 affected / 294 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 6 affected / 294 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 294 at risk

Adverse event: Facet joint syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Numbness/weakness
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 8 affected / 294 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 4 affected / 294 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 294 at risk

Adverse event: Patellar malalignment
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Recurrent shoulder instability
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 5 affected / 294 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 294 at risk

Adverse event: Shoulder subluxation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Snapping Iliopsoas Tendon
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 294 at risk

Adverse event: Stiffness/tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Synovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Withdrawal symptoms
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 294 at risk