ZIMMER BIOMET, INC. RETROGRADE FEMORAL NAIL PURPLE 11.5MM DIAMETER 44CM LENGTH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Pseudoaneurysm (2605)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported patient was revised approximately one month post-implantation due to postoperative compartment syndrome with hematoma formation in pseudoaneurysm hemorrhage of the right profunda femoral artery.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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Upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.A pseudoaneurysm is a false aneurysm that occur at the site of arterial injury.It occurs when an arterial wall is injured and the leaking blood collects in the surrounding tissue, resulting in locally contained hematoma with turbulent blood flow and a neck that typically does not close spontaneously once past a certain size.Unlike a true aneurysm, a pseudoaneurysm does not contain any layer of the vessel wall.Instead, there is blood containment by a wall developed with the products of the clotting cascade.In a true aneurysm, the artery or vessel weakens and bulges, sometimes forming a blood-filled sac and is contained in the arterial wall.As the device was not reported revised, this is considered a procedure related event and the device can be definitively ruled out as causing or contributing to the reported event.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space (or in this case within the pseudoanuerysm).A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.
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Manufacturer Narrative
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Upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.A pseudoaneurysm is a false aneurysm that occur at the site of arterial injury.It occurs when an arterial wall is injured and the leaking blood collects in the surrounding tissue, resulting in locally contained hematoma with turbulent blood flow and a neck that typically does not close spontaneously once past a certain size.Unlike a true aneurysm, a pseudoaneurysm does not contain any layer of the vessel wall.Instead, there is blood containment by a wall developed with the products of the clotting cascade.In a true aneurysm, the artery or vessel weakens and bulges, sometimes forming a blood-filled sac and is contained in the arterial wall.As the device was not reported revised, this is considered a procedure related event and the device can be definitively ruled out as causing or contributing to the reported event.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space (or in this case within the pseudoanuerysm).A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.
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Search Alerts/Recalls
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