In a review of all available information, this subscapularis insufficiency (e.G.Failed subscapularis repair) reported in experience (b)(4) resulted in glenoid loosening.Subscapularis failure after a total shoulder arthroplasty (tsa) is a failure mode associated with the procedure and is not implant related.However, this cannot be confirmed because the component was not returned for evaluation.Per ifu # (b)(4) rev.M states in post op instructions: all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Patients must be informed that their weight and activity level may affect the longevity of the implant.Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds as this may indicate positional changes in the implant that could lead to premature failure.This device is used for treatment not diagnosis.
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