MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED LEFT SIZE G; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Date 09/17/2021

Event Type  Injury  

Event Description

It was reported a patient developed a dvt within the left lower leg seven days after the procedure.The dvt was resolved with eliquis.No further information is available.

Manufacturer Narrative

(b)(4).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.Additional associated products & mdrs ----------------------------------------------------- 42504606601 femur cemented standard left size 9 lot# 64890211 mdr: 0001822565-2024-00515 42560113514 stem extension straight splined uncemented 14mmdia 135mm lot# 64911523 mdr: 0001822565-2024-00520 42556806605 femoral posterior augment cemented size 9, 9+ 5mm lot# 64911460 mdr: 0001822565-2024-00519 42512800912 articular surface fxd bearing constrained condylar knee l 12mm lot# 64709590 mdr: 0001822565-2024-00517 42560007514 stem extension tapered cemented 14mm dia +75mm lot# 64769750 mdr: 0001822565-2024-00518 42545000508 tibial central cone size fixed tibia lot# 64788570 mdr: 0001822565-2024-00521 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.

• Brand Name: TIBIA FIXED CEMENTED LEFT SIZE G
• 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: 18701786
• MDR Text Key: 335300218
• Report Number: 0001822565-2024-00516
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181947
• 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: 02/13/2024

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: 42542007901
• Device Lot Number: 64817981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2020
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White