MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM A +3MM OFFSET POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	00-4349-036-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/11/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right reverse arthroplasty, subsequently, approximately one (1) month later the patient experienced left sided facial droop, slurred speech, and ataxia due to cerebral vascular accident and was admitted to the hospital.Patient was prescribed a daily dose of aspirin and the event was reported to be resolved two (2) days later.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02658, 0001822565-2022-02661, 0001822565-2022-02662, 0001822565-2022-02663, 0001822565-2022-02664.Concomitant medical products: item#: 00434901213, 12mm a 130mm length humeral stem; lot#: 62248463.Item#: 0043490361, 36mm a glenosphere; lot#: 62234748.Item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777.Item#: unknown, unknown screw length 36; lot#: unknown.Item#: unknown, unknown screw length 42; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02658-1, 0001822565-2022-02661-1, 0001822565-2022-02662-1, 0001822565-2022-02663-1, 0001822565-2022-02664-1.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.A stroke can happen to anyone at any time.It occurs when blood flow to an area of brain is cut off.When this happens, brain cells are deprived of oxygen and begin to die.Stroke is also known as the following: cva (cerebral vascular accident), tia (transient ischemic attack) and brain infarction.There are two classifications of stroke.A hemorrhagic stroke is when a brain aneurysm bursts or a weakened blood vessel leaks.An ischemic stroke occurs when a blood vessel carrying blood to the brain is blocked by a blood clot which can be cardiogenic due to underlying atrial fibrillation or from anti- or hypercoagulates which change the viscosity of the blood.A perioperative stroke is a serious and rare complication that may occur when a patient undergoes a surgical procedure and typically requires medical intervention.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: 36MM A +3MM OFFSET POLY LINER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 15419075
• Report Number: 0001822565-2022-02660
• Device Sequence Number: 2620811
• Product Code: HSD
• UDI-Device Identifier: 00889024269064
• UDI-Public: (01)00889024269064(17)200731(10)62114032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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 Expiration Date: 07/31/2020
• Device Model Number: 00-4349-036-03
• Device Catalogue Number: 00434903603
• Device Lot Number: 62114032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG