MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IDENTITY SHOULDER SYSTEM STANDARD HUMERAL STEM; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pneumonia (2011)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 00436202000, base plate uncemented 20 mm post length, lot # 66054345.Catalog #: sahtnem6, humeral tray neutral -6mm ext, lot # 66302446.Catalog #: 110031418, cr prolong 36mm brng std, lot # 66138493.Catalog #: 00436003600, glenosphere centric 36 mm diameter +0 mm, lot # 66134612.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00892, 0001822565-2024-00894, 0001822565-2024-00895, 0001822565-2024-00896 h3 other text : remains implanted.
Event or Problem Description
It was reported that the patient underwent an initial right total shoulder arthroplasty approximately a month ago.Subsequently, 2 days later the patient developed pneumonia and pulmonary embolism.Medical treatment included antibiotics, anticoagulants, and oxygen.The issue was resolved 13 days later.Attempts have been made and there is no further information at this time.
Event or Problem Description
No additional information to report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was reviewed based on medical records provided; review of the device history records was not performed, as it was determined that the reported event was unrelated to the implanted zimmer biomet devices due to the following: 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 2 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 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, therefore our complaint category, medical: procedure related would be appropriate.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, therefore our complaint category, medical: procedure related would be appropriate.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: IDENTITY SHOULDER SYSTEM STANDARD HUMERAL STEM
• Common Device Name: EXTREMITY IMPLANT
• 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: 18898794
• Report Number: 0001822565-2024-00893
• Device Sequence Number: 7477351
• Product Code: HSD
• UDI-Device Identifier: 00889024627062
• UDI-Public: (01)00889024627062(17)331201(10)66422732
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SAHS1109
• Device Lot Number: 66422732
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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: Other
• Patient Sex: Female
• Patient Weight: 99 KG