MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PATELLA SIZE 1 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Atrial Fibrillation (1729)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01653, 0001822565-2022-01654, 0001822565-2022-01655.Medical devices: gender solutions female (gsf) femoral nonporous size 3, left catalog#: 00541401601 lot#: 64891382; articular surface ultracongruent size 1 2 left 9 mm height catalog#: 00542801109 lot#: 64468983; modular cemented tibial baseplate size 1, left catalog#: 642000210 lot#: 65227604.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left total knee arthroplasty and prescribed medication two days post-op.Subsequently, approximately a week later, the patient was admitted to the hospital with atrial fibrillation and a pulmonary embolism.The issues were resolved by the following day with no further complications reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted, to relay additional information.It was reported, a patient had a total knee arthroplasty.Subsequently, approximately one week later, developed atrial fibrillation and a pulmonary embolism.Procedural related complications are influenced by the "type of surgery, patients pre-existing comorbid state, and perioperative management".Side effects of the administration of anesthesia are a known cause of chest pain, ekg changes and mi, during the intraoperative and postoperative recovery.Elective total joint procedures have cardiac workup, prior to surgery to "clear" them of surgery.Hence, reducing their risk for these cardiac related complications.Patients are at the highest risk immediately post op, but continue to be at risk for several weeks post op.As the reported complaint indicated, a cardiac postoperative complication developed.And it can be implied medical treatment was warranted to treat the complication.Procedural related complications are influenced by the "type of surgery, patients pre-existing comorbid state, and perioperative management".If a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism.Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.As the complaint indicated, the patient developed a post-operative complication, it can be implied medical intervention was completed to treat the pe.

• Brand Name: ALL POLY PATELLA SIZE 1 8 MM THICKNESS
• 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: 14577437
• Report Number: 0001822565-2022-01656
• Device Sequence Number: 20377815
• Product Code: JWH
• UDI-Device Identifier: 00889024189591
• UDI-Public: (01)00889024189591(17)251108(10)64825664
• 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: 2022
• 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): 06/24/2022

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 Expiration Date: 11/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 00542000801
• Device Lot Number: 64825664
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White