MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL TRAY NEUTRAL -6MM EXT; PROSTHESIS, SHOULDER

Catalog Number SAHTNEM6

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

Patient Problems Hypoxia (1918); Respiratory Failure (2484); Aspiration Pneumonitis (4455)

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cat: sahs1208 lot: 65988703 humeral stem micro size 8.Cat: 110031418 lot: 66272799 cr prolong 36mm brng std.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 aspiration 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 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 - 2024 - 00567; 0001822565 - 2024 - 00569.

Event Description

It was reported patient was readmitted one day post implantation due to acute respiratory failure with hypoxia and suspected aspiration pneumonia.The patient was treated with supplemental oxygen, cta performed, incentive spirometer, chocardiogram, and prescription for proton pump inhibitor/antacid medication and protonix.The patient was discharged without complications.No additional patient consequences were reported.

• Brand Name: HUMERAL TRAY NEUTRAL -6MM EXT
• Type of Device: PROSTHESIS, SHOULDER
• 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: 18747554
• MDR Text Key: 335873611
• Report Number: 0001822565-2024-00568
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

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 Catalogue Number: SAHTNEM6
• Device Lot Number: 66166361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG