MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA; PROSTHESIS KNEE

Model Number N/A

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: persona femur cemented cruciate retaining (cr) catalog # 42502605802 lot # 66440727 persona articular surface medial congruent (mc) catalog # 42522100311 lot # 65929917 heraeus medical catalog # 5036963 lot # 67841256 heraeus medical catalog # 5036963 lot # 68331243 procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.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.

Event Description

It was reported patient developed a deep vein thrombosis and was treated with eliquis post implantation.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: PERSONA TIBIA
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19166604
• MDR Text Key: 340860114
• Report Number: 0001822565-2024-01376
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024632097
• UDI-Public: (01)00889024632097(17)331108(10)66086971
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42536006702
• Device Lot Number: 66086971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: Black Or African American