PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

Exclusion Criteria

• •The patient is:
• •* A prisoner
• •* Mentally incompetent or unable to understand what participation in the study entails.
• •* A known alcohol or drug abuser
• •* Anticipated to be non-compliant
• •The patient has a neuromuscular disorder, vascular disorder or other condition that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• •The patient has local bone tumors and/or cysts in the portion of bone to be retained in the operative hip that could inhibit implant fixation.
• •The patient has insufficient bone stock or poor bone quality to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be required to assess the presence of adequate bone stock.
• •The patient has rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray.
• •The patient has osteoradionecrosis in the affected hip.
• •The patient has a neuromuscular condition in the ipsilateral or contralateral limb which affects lower limb function.
• •The patient has loss of abductor musculature in the affected hip.
• •The patient has a vascular (large and small vessel disease) insufficiency.
• •The patient has had previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be operated.
• •The patient has had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
• •The patient has an acute femoral neck fracture in the operative hip.
• •The patient has had a procedure on the operative hip in the last 6 months (i.e. arthroscopy, ORIF femoral neck fracture, etc).
• •The patient has undergone a total hip replacement, endoprosthesis, or surface arthroplasty of the contralateral (opposite side) hip within the past 6 months regardless of whether the previous hip was enrolled in this clinical study.
• •The patient has a moderate to severe limb length discrepancy greater than 3.2 cm.
• •The patient has an active, old or remote infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
• •The patient has poor skin coverage around the affected hip joint.
• •The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
• •The patient is currently receiving, or within the past three months, has received any drug known to potentially interfere with bone/soft tissue healing (e.g. long-term chronic systemic steroid or inhaler steroid therapy).
• •The patient has received an investigational drug or device within the previous 6 months.
• •The patient is known to be pregnant.
• •The patient is unwilling or unable to give informed consent, or to comply with the followup program.
• •The patient is known to have a highly communicable disease that may limit follow-up.
• •The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal and ceramic.
• •The patient is Grade III obese with a Body Mass Index (BMI) \> 35.