MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); 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); Cardiac Enzyme Elevation (1838); Hypoxia (1918); Thrombosis/Thrombus (4440)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent an initial left total knee arthroplasty.Approximately 7 days post implantation, the patient presented with shortness of breath.The patient was admitted for pulmonary embolism without acute cor pulmonale, elevated troponins, and acute myocardial injury.The patient was placed on additional anticoagulants and oxygen and discharged 3 days later.Approximately 2 weeks later, the patient was diagnosed with deep vein thrombosis of the left calf.The patient is taking eliquis.No further complications were reported at this time.
Additional Manufacturer Narrative
(b)(4).A 71 year old female developed pulmonary embolism on post op day 7 and required hospital admission for treatment of pe.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).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03464, 3007963827-2022-00321, 0002648920-2022-00252.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15971233
• Report Number: 3007963827-2022-00322
• Device Sequence Number: 5525739
• Product Code: MBH
• UDI-Device Identifier: 00889024237247
• UDI-Public: (01)00889024237247(17)270314(10)65302444
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• 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
• Report Date (Section B): 12/13/2022

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 Model Number: N/A
• Device Catalogue Number: 42512400710
• Device Lot Number: 65302444
• 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: 12/01/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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: Life Threatening
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Race: White