Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Wound Dehiscence (1154); Pain (1994)
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Event Date 12/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: 195753, vanguard xp tibial tray, 677680.195807, vanguard xp left lateral bearing, 998780.195877, vanguard xp tibial bearing, 359540.184764, vanguard series-a standard patella,483590.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07090, 0001825034 - 2017 - 07091, 0001825034 - 2017 - 07092, 0001825034 - 2017 - 07093.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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Event Description
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It was reported that a patient experienced unexplained pain and wound dehiscence following surgery.The wound was left open and then dressed.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Manufacturer Narrative
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The 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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Event Description
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It was reported that a patient experienced unexplained pain and wound dehiscence following surgery.The wound was left open and then dressed.The patient received antibiotics to treat the wound.Approximately forty days post-onset of adverse event, the patient underwent a manipulation under anesthesia to have the stitch sinus excised and the wound closed.The surgeon noted that the patient's wound dehiscence was most likely related to the patient continuing to smoke.It was further reported at approximately three months post-onset of adverse event, that the wound had completely healed.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Event Description
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It was reported the patient continues to have ongoing pain approximately three years post-implantation.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.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: 0001825034-2017-07090-3, 0001825034-2017-07091-3, 0001825034-2017-07092-3, 0001825034-2017-07093-3.
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Event Description
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It was reported that a patient experienced unexplained pain and wound dehiscence following surgery.The wound was left open and then dressed.Patient continues to have ongoing pain approximately one year post-implantation.The patient received physiotherapy and pain medication to relief the pain.Attempts to obtain additional information have been made; however, no more is available.
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Search Alerts/Recalls
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