MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Embolism/Embolus (4438)

Event Date 11/12/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial left tka.Approximately 5.5 weeks later, the patient presented at the emergency department with shortness of breath and right flank pain.Bilateral pulmonary embolisms were diagnosed on ct and left lower extremity deep vein thrombosis confirmed by ultrasound.The patient was placed on additional anticoagulants and discharged the next day.No further complications have been reported.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: 42532006401 - tibia cemented 5 degree stemmed left size c - 65121343; 42572005801 - femur cemented cruciate retaining (cr) narrow nitrided left size 5 - 65475953; 42540200032 - all-poly patella cemented 32 mm diameter - 65499703; unknown - unknown palacos bone cement - 97971054.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.Despite prophylaxis, dvts can still develop which can then break free within the vessel and occlude or block the blood flow in the lungs, known as a pulmonary embolism (pe).As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00307, 0001822565-2022-03386, 0002648920-2022-00240.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT
• 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: 15923879
• MDR Text Key: 304885349
• Report Number: 0001822565-2022-03387
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468900
• UDI-Public: (01)00889024468900(17)241130(10)64557822
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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: 42512100311
• Device Lot Number: 64557822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• 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; Other
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White