(b)(4).Report source: (b)(6).The product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00751, 0002648920-2021-00307, and 0002648920-2021-00309.Previously incorrectly reported under mfr 0001822565-2019-04477.
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It was reported that patient is experiencing aches and pains, loss of balance, difficulty walking, chronic fatigue, stomach upset, reflux, erratic blood pressure, spasmodic confusion, headaches, and heart thumping approximately 5 or 6 months post right hip bipolar arthroplasty.No revision surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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