Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)
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Event Date 02/20/2024 |
Event Type
Injury
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Manufacturer Narrative
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(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: 0009613350-2024-00104.
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Event Description
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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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Event Description
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It was reported that patient underwent a right hip revision approximately 3 weeks after initial implant due to trauma where zb devices were implanted.Subsequently, approximately 8 years later, the patient experienced a sudden onset of pain, difficulty ambulating and limited mobility.The patient underwent a second revision to remove a fractured stem component.Attempts have been made and additional information is not available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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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Search Alerts/Recalls
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