(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Implanted in 2008.Concomitant medical products: item # unk, hip-unknown-stems-unk, lot # unk, item # unk, hip-mom-cups-unk, lot # unk.The event occurred in (b)(6).Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10960, 0001825034-2018-10961.
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It was reported that the patient was implanted in left hip with magnum m2a-38 devices approximately 10 years ago.Subsequently, the patient is affected by depression because of the periodical follow up for elevated ion levels.Attempts have been made, and no further information has been provided.
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