MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR CEMENTED TIBIAL BASEPLATE SIZE 1 LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Medical product: gender solutions female (gsf) femoral component nonporous size 3, left: catalog#00541401601, lot#64857681; articular surface ultracongruent "size 1 2 left 11 mm height": catalog#00542801111, lot#64849694; all poly patella size 2 8 mm thickness: catalog#00542000802, lot#64825650; unknown bone cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-00223; 0001822565-2023-00225; 0001822565-2023-00226.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 or Problem Description
No further event information at time of this report.
Additional 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.

• Brand Name: MODULAR CEMENTED TIBIAL BASEPLATE SIZE 1 LEFT
• Common Device Name: 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: 16254699
• Report Number: 0001822565-2023-00224
• Device Sequence Number: 5249857
• Product Code: JWH
• UDI-Device Identifier: 00889024259355
• UDI-Public: (01)00889024259355(17)310719(10)65027101
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 642000210
• Device Lot Number: 65027101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White