MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pneumonia (2011)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products:unknown - unknown femoral component - unknown.Unknown - unknown articular surface - unknown.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Pneumonia is a well-known postoperative complication that typically requires medical intervention and possibly even hospitalization for more aggressive medical management.Within a two-hour postoperative window, the protective reflexes of the oropharyngeal passages are depressed, and the patient can aspirate.The reason for postoperative pneumonia is typically due to aspiration of subglottic secretions containing bacteria.Once the bacteria enter the respiratory tract, they can replicate and advance into aspiration pneumonia.Patient that have known history of respiratory or lung diseases such as copd, asthma, or are immune suppressed are at increased risk for developing this complication.Pneumonia is a procedural related complication resulting from intubation during the procedure and is considered a hospital-acquired condition.As the complaint indicates, a postoperative complication of pneumonia developed, and medical intervention was required for treatment.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: 0001822565-2023-00126.0001822565-2023-00128.

Event Description

It was reported that a patient underwent a right unilateral knee arthroplasty and subsequently developed pneumonia requiring antibiotics approximately 10 days later.All components remain implanted.Attempts have been made and all available information has been provided.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• Type of Device: 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: 16161457
• MDR Text Key: 307328689
• Report Number: 0001822565-2023-00127
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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
• Report Date: 01/11/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White