TESS V3 Modular Total Shoulder System PMCF

Korábbi kezelés

• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
• Patient who displays any of the following contra-indications cannot be included in this study:
  • Local or systemic infections
  • Severe muscular, neurological, or vascular deficiency of the affected joint
  • Poor bone quality likely to prevent osseointegration or to affect the long-term stability of the implant (Paget's disease, osteoporosis)
  • Any concomitant conditions likely to affect the function of the implant
  • Allergy to any of the implant components
  • Do not use the modular humeral version (screwed connection) in cases where the corolla cannot be two-thirds covered with bone stock and including the screwed modular stem/corolla junction

Más betegség

• Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study

Egyéb

• 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 is 18 years or older and skeletally mature
• Patient is capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program
• Patient gave consent to take part in the study by signing the Informed Consent Form
• Patient operated from January 2013 and received the Anatomic or Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function
• Patient has adequate quality and quantity of bone stock to support the prosthesis
• Patient meets at least one of the following indications:
  • For anatomic type:
• Centered osteoarthritis of the shoulder
• Humeral head fractures
• Rheumatoid arthritis (with intact rotator cuff)
• Avascular necrosis of the humeral head
• Revision of a hemi-arthroplasty with a total arthroplasty
• Revision of a reverse prosthesis with an anatomic prosthesis
• Revision to increase the size of the stem (length and/or diameter)
• Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
  • For reverse type:
• Offset osteoarthritis of the shoulder
• Massive and non-repairable rotator cuff tears
• Rheumatoid arthritis (with degenerative rotator cuff)
• Revision of an anatomic prosthesis with a reverse prosthesis
• Revision to increase the size of the stem (length and/or diameter)
• Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis