MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Model Number N/A

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

Patient Problems Pulmonary Embolism (1498); Angina (1710); Cardiac Arrest (1762); Pain (1994); Pulmonary Edema (2020); Ischemic Heart Disease (2493); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/21/2023

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 01.04555.440; lot# 3100396; sidus stem-free shoulder, humeral head, 44-16; item# sagl2023; lot# 65268598; monoblock 3 peg size 3 for cemented use only; item# 5036963, lot# 60671053; palacos bone cement.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00215, 0009613350 - 2023 - 00216.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient had an initial left total shoulder arthroplasty and approximately 1.5 month later developed chest pain with a cxr showing a mildly enlarged heart and underwent a successful right transfemoral heart catheterization.Stent placement was at the pci of the rca.Few days later, had an office appointment where the patient reports pain and swelling to the left shoulder.A needle aspiration was completed and showed purulent fluid that was consistent with infection.The patient underwent stage i of a two stage revision where all implants were removed without complication.15 days later, the patient had a follow-up appointment where it was noted the incision was healing well with minimal erythema and was ordered to continue the course of antibiotic therapy and follow-up again in 1 week.Subsequently, the patient was reporting increased shortness of breath, he slumped over in bed, becoming unresponsive and pulseless.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Devices are used for treatment.Sudden cardiac arrest occurs suddenly and often without warning.It happens when an electrical malfunction in the heart causes an irregular heartbeat (arrhythmia).With its pumping action disrupted, the heart can't pump blood to the brain, lungs, and other organs.When this occurs, a person loses consciousness and has no pulse.Death occurs within minutes if the person does not receive treatment.Symptoms that could occur prior to cardiac arrest include chest discomfort, shortness of breath, weakness, and fast-beating or fluttering heart.The immediate symptoms include sudden collapse, no pulse, no breathing, and a loss of consciousness.The infection leading to removal of the device was declared to be unrelated to the device as all sterile certs were found conforming.Due to the patient¿s ongoing cardiac events, including a recent heart catheterization and heart failure, the complications that occurred leading up to expiration were related to the patient¿s ongoing chronic medical conditions and disease process, therefore this is not a device related event.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.

Event Description

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

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17036912
• MDR Text Key: 316278669
• Report Number: 0009613350-2023-00216
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024397187
• UDI-Public: (01)00889024397187(17)320518(10)3112046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171858
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0104555130
• Device Lot Number: 3112046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 116 KG