(b)(4).G2: report source switzerland.Product has been received by zimmer biomet and 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: 0009613350-2024-00102.
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It was reported that patient underwent revision approximately 9 years post-implantation due to revitan fracture.The patient reported pain in the hip approximately 3 months ago, along with history of trauma to the right side, decreased ability to walk without a cane, and restriction of mobility and activities of daily living.Attempts have been made and additional information on the reported event is unavailable at this time.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h11.Upon reassessment it was found that this device did not cause or contribute to the reported event.The initial report was forwarded in error.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.
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