MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left tka.Approximately 5.5 weeks later, the patient presented at the emergency department with shortness of breath and right flank pain.Bilateral pulmonary embolisms were diagnosed on ct and left lower extremity deep vein thrombosis confirmed by ultrasound.The patient was placed on additional anticoagulants and discharged the next day.No further complications have been reported.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42572005801 - femur cemented cruciate retaining (cr) narrow nitrided left size 5 - 65475953, 42512100311 - articular surface medial congruent (mc) left 11 mm height use with tibia sizes c-d/cr femur sizes 4-5 - 64557822, 42540200032 - all-poly patella cemented 32 mm diameter - 65499703, unknown - unknown palacos bone cement - 97971054.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03386, 0001822565-2022-03387, 0002648920-2022-00240.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C
• 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: 15923883
• Report Number: 3007963827-2022-00307
• Device Sequence Number: 15151756
• Product Code: JWH
• UDI-Device Identifier: 00889024471016
• UDI-Public: (01)00889024471016(17)310822(10)65121343
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: 42532006401
• Device Lot Number: 65121343
• 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: 11/23/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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
• 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: Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White