Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Syncope (1610); Fall (1848)
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Event Date 01/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: vanguard cr ilok fem-rt catalog # 183006 lot # 6494487, vngd ant stab brg catalog # 189061 lot # 959300, series a pat std catalog # 184764 lot # 069360.The complainant has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2020-00471, 0001825034-2020-00473, 0001825034-2020-00474.Remains implanted.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient experienced a syncopal episode at home which resulted in a laceration to the nasal bridge of nose.
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Event Description
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From additional information, it was further reported that the patient was prescribed physical therapy approximately one month after surgery for weakness and difficulty with ambulating.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Anesthesia administration has common side effects which can cause a syncopal episode.Syncope is defined as a temporary decrease in the amount of blood that flows to the brain in which the patients body will perceive as fainting or passing out.Syncopal episodes are typically caused by a sudden drop in blood pressure, heart rate or decreased volume which can occur post op from medication, changing positions too quickly and/or holding their breath.Anesthetic medication typically takes the average healthy patient 24 hours post administration to fully metabolize.As this specific patient was discharged the same day of surgery, the event can be related to the unmetabolized anesthetic medications provided intra and post op.As the complaint indicated the patient developed a post-operative complication requiring medical treatment, the complaint category, medical: procedure related would be appropriate.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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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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From additional information, it was reported that the patient not only had a syncopal episode, but also fell.Further, it was reported that the patient was taking pain medications.Finally, the patient was referred to a plastic surgeon for repair and the laceration was corrected with sutures.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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Search Alerts/Recalls
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