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TESS V3 Modular Total Shoulder System PMCF

TerminatedN/A

Sponsor: Zimmer Biomet

Conditions: Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Revision

Interventions: Anatomic TESS V3, Reverse TESS V3

Countries: France

This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Locations (2)

Lyon, France
Saint-Jean-de-Védas, France