MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PATELLA SIZE 2 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pulmonary Embolism (1498)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: gender solutions female (gsf) femoral component nonporous size 3, left: catalog#00541401601, lot#64857681; modular cemented tibial baseplate size 1, left for cemented use only: catalog#642000210, lot#65027101; articular surface ultracongruent "size 1 2 left 11 mm height": catalog#00542801111, lot#64849694; unknown bone cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-00223; 0001822565-2023-00224; 0001822565-2023-00225.The products will not be returned to zimmer biomet for evaluation, as they remain implanted.The investigation is in progress.Upon completion of the investigation or receipt of additional information, a follow-up mdr will be submitted.

Event Description

It was reported via a clinical study four days post-implantation implantation, patient presented at the emergency department for a pulmonary embolism.No further complications have been reported at subsequent follow-ups and the patient is reportedly satisfied with the prosthesis one year post-implantation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: bone smartset cement: catalog#: ni, lot#: 9722464.A review of the device history records was not performed as the root cause of the reported event was determined to be unrelated to the implanted devices.The root-cause of the reported event can be traced to non-device related factors.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information at time of this report.

• Brand Name: ALL POLY PATELLA SIZE 2 8 MM THICKNESS
• 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: 16254723
• MDR Text Key: 308274369
• Report Number: 0001822565-2023-00226
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024189607
• UDI-Public: (01)00889024189607(17)251006(10)64825650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173057
• 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,Followup
• Report Date: 02/03/2023

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: 00542000802
• Device Lot Number: 64825650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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.; SEE H10 NARRATIVE.
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White