The objectives of this study are to confirm the early to mid-term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty.
The primary objective of this post market clinical follow-up (PMCF) study is the assessment of safety by recording and analyzing the survival of the implant system at 2 years post-implantation. Safety will also be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation, and/or procedure should be specified.
The secondary objective is the assessment of functional performance and clinical benefits of the Z1 Femoral Hip System demonstrated by recording patient-reported clinical outcomes measures (PROMs).
Patient is at least 18 years old and skeletally mature
Patient is physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol, including all scheduled study evaluations
Patient, or the patient's legally authorized representative, is willing and able to participate in the Informed Consent process and provide their consent
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases
Revision arthroplasty
Acute, chronic, local, or systemic infection(s)
Severe muscular, neural, or vascular diseases that endanger the limb(s) involved
Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible