(b)(4).Concomitant medical products: patella reamer blade with pilot hole, catalog #: 00597909535, lot #: 54067300, trabecular metal ps tibial, catalog #: 00588605614, lot #: 6037644, nexgen tm standard patella, catalog #: 00587806535, lot #: 60448090.Customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.When the investigation is complete, a follow-up report will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Device remains implanted in patient.
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It was reported patient underwent right total knee arthroplasty.Subsequently, patient experienced a burning in his knee since 9 months post-op.Patient also reports loosening of the muscles, causing knee to be loose.There is a continuous burning that affects of the leg muscles, going up into buttocks and now affecting the patient's chest and arm.
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