MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION 3MM OFFSET SPLINED UNCEMENTED 11 MM DIAMETER +135 MM LENGTH; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumonia (2011); Embolism/Embolus (4438)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00903, 0001822565-2022-00904, 0001822565-2022-00905, 0001822565-2022-00906, 0001822565-2022-00907, 0001822565-2022-00908, 0001822565-2022-00909, 0001822565-2022-00910, 0001822565-2022-00911, 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 distal augment cemented size 5, 5+ 5 mm thickness item# 42556605805 lot# 64602337.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.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 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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10 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.

Event Description

No further event information available at the time of this report.

• Brand Name: STEM EXTENSION 3MM OFFSET SPLINED UNCEMENTED 11 MM DIAMETER +135 MM LENGTH
• Type of Device: 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: 13942653
• MDR Text Key: 289446916
• Report Number: 0001822565-2022-00912
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868250019
• UDI-Public: (01)00887868250019(17)291031(10)64559287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42560313511
• Device Lot Number: 64559287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White