(b)(4).Concomitant medical products: catalog #: 00592601102, patello-femoral trochlea component, lot # 62936327.Catalog #: 00584202408, articular surface size 4, lot # 62697221.Catalog #: 00584200402, tibial component precoat, lot # 62828687.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr 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.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-07029.
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It was reported that a patient underwent an initial knee procedure on approximately 3 years ago.Subsequently, the patient was revised due to pain, loosening, and instability.
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