MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL DISTAL AUGMENT CEMENTED SIZE 5, 5+ 5 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	Pneumonia (2011); Embolism/Embolus (4438)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient reported cough, shortness of breath, rib pain, back pain, nausea/vomiting, and diarrhea which progressed to difficulty breathing and the patient was hospitalized approximately three weeks post implantation with pulmonary embolism and pneumonia.These issues were resolved approximately seven months later with medical treatment.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00903, 0001822565-2022-00904, 0001822565-2022-00906, 0001822565-2022-00907, 0001822565-2022-00908, 0001822565-2022-00909, 0001822565-2022-00910, 0001822565-2022-00911, 0001822565-2022-00912, and 3007963827-2022-00079.Medical product: femur cemented standard right size 5 item# 42504605802 lot# 64541285.Femoral posterior augment cemented size 5, 5+ 5 mm thickness, item# 42556805805, lot# 64468789.Femoral central cone size medium, item# 42545001012, lot# 64470406.Stem extension straight splined uncemented 14 mm diameter +135 mm length, item# 42560113514, item# 64542409.Tibia fixed cemented right size d stem extension use required, item# 42542006702, lot# 64207430.Tibial augment cemented half block right medial size cd 5 mm thickness, item# 42555803405, lot# 64353978.Tibial augment cemented half block right lateral size cd 5 mm thickness, item# 42555803205, lot# 64333007.Tibial central cone size x-small, item# 42545000510, lot# 64189844.Stem extension 3mm offset splined uncemented 11 mm diameter +135 mm length, item# 42560313511, lot# 64559287.Articular surface fixed bearing (cps) right 14 mm height, item# 42522600414, lot# 64525555.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.It was reported a patient had a revision of a total knee arthroplasty.Subsequently, approximately three weeks later, required medical intervention for pneumonia and a pulmonary embolism.Procedural related complications are influenced by the "type of surgery, patients pre-existing comorbid state, and perioperative management." pneumonia is a well-known postoperative complication that typically requires medical intervention and possibly even hospitalization for more aggressive medical management.During the immediate post-operative period for a period of two hours, the protective reflexes are depressed, and the patient can aspirate.Typically, the reason for postoperative pneumonia is the aspiration of subglottic secretions containing bacteria.Once the bacteria enter the respiratory tract they can replicate if the conditions are right and advance into aspiration pneumonia.Patient that has a known history of respiratory or lung diseases i.E., copd or immune suppressed are at increased risk for developing this complication.Pneumonia is a procedural related complication resulting from intubation during the procedure.As the complaint indicates a postoperative complication of pneumonia developed, it can be implied that medical intervention was completed.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.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL DISTAL AUGMENT CEMENTED SIZE 5, 5+ 5 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13942569
• Report Number: 0001822565-2022-00905
• Device Sequence Number: 6506066
• Product Code: JWH
• UDI-Device Identifier: 00889024556720
• UDI-Public: (01)00889024556720(17)291130(10)64602337
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/22/2022

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: 42556605805
• Device Lot Number: 64602337
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White