MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETROGRADE FEMORAL NAIL PURPLE 11.5MM DIAMETER 44CM LENGTH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: RETROGRADE FEMORAL NAIL PURPLE 11.5MM DIAMETER 44CM LENGTH
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12461435
• MDR Text Key: 271074577
• Report Number: 0001822565-2021-02613
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47249444011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG