MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CR TM STANDARD FEMORA; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Hematoma (1884)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona tm modular tibia catalog # 42530008302, lot # 64696483.Persona articular surface medial congruent (mc) catalog # 42522100910, lot # 64453814.Persona all poly patella catalog # 42540000041, lot # 64775343.Customer has indicated that the product will not be returned because it remains implanted.Multiple mdr reports were filled for this event: 0001822565-2020-03709, 3007963827-2020-00290, 0002648920-2020-00487.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.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 time frames of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.Appropriate complaint category medical: hematoma.As the complaint indicates this patient had an abnormal, unexpected hematoma that required medical intervention.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.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was noted to experience a hematoma.The patient underwent a ugi right calf aspiration.However, no revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

Event Description

From additional information received, it was reported that the patient was admitted to the hospital due to new onset atrial fibrillation with rapid ventricular response secondary to anemia from bleeding into a hematoma at the surgical site.The afib resolved with medical treatment.

Manufacturer Narrative

Anemia is a condition that develops when your blood is deficient in red blood cells (hemoglobin), which limits the hemoglobin's ability to carry enough oxygen throughout the body's system.With the lack of oxygen the patient can experience, light headedness, weakness, fatigue, fainting, dizziness, elevated heart rate.Anemia can be associated with different medical conditions or can be directly related to blood loss during a trauma, surgical procedure or surgical complication.Anemia depending on the cause can be monitored and treated minimally or if hemoglobin is significantly low, it could be indicated that medical intervention is necessary to treat, i.E.Administering blood or other medical interventions.As the complaint indicates this patient had an abnormal, unexpected cardiac response directly correlated with postop bleeding into the hematoma and required medical intervention.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received, the patient underwent a second hematoma drainage attempt.

• Brand Name: PERSONA CR TM STANDARD FEMORA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10784262
• MDR Text Key: 214523828
• Report Number: 0001822565-2020-03708
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: 42502807002
• Device Lot Number: 64592479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Weight: 117