MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Launched by ZIMMER BIOMET · Jun 26, 2019

Keywords

ClinConnect Summary

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,2,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinic...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
• • Patient must be 18 years of age or older.
• * Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:
• • non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• • rheumatoid arthritis,
• • revision where other devices or treatments have failed,
• • correction of functional deformity,
• • fractures of the proximal humerus where other methods of treatment are deemed inadequate,
• • difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable or may be inadequate.
• Exclusion Criteria:
• • Absolute contraindications include infection, sepsis, and osteomyelitis.
• * Relative contraindications include:
• • Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
• • Osteoporosis
• • Metabolic disorders which may impair bone formation
• • Osteomalacia
• • Distant foci of infections which may spread to the implant site
• • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• • Patient is a prisoner.
• • Patient is a current alcohol or drug abuser.
• • Patient is known to be pregnant or breastfeeding.
• • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.