MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Catalog Number 115310

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).D10: cat: 010000589 lot: 66100983 comp rvrs 25mm bsplt ha+adptr 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: 0001825034 - 2024 - 00449.

Event Description

It was reported that the patient had right reverse total shoulder arthroplasty.After one day of surgery, the patient was readmitted due to acute respiratory failure with hypoxia and suspected aspiration pneumonia.The patient was treated with supplemental oxygen, cta performed, incentive spirometer, echocardiogram, and prescription for proton pump inhibitor/antacid medication and protonix.The patient was discharged without complications.No additional patient consequences were reported.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18761984
• MDR Text Key: 336025284
• Report Number: 0001825034-2024-00450
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• 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: 02/22/2024

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: 115310
• Device Lot Number: J7609429
• 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: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG