ZIMMER BIOMET, INC. UNKNOWN SCREW LENGTH 42; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 03/11/2013 |
Event Type
Injury
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Event Description
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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.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02658, 0001822565-2022-02660, 0001822565-2022-02661, 0001822565-2022-02662, 0001822565-2022-02663.Concomitant medical products: item#: 00434901213, 12mm a 130mm length humeral stem; lot#: 62248463, item#: 00434903603, 36mm a +3mm offset poly liner; lot#: 62114032, 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.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.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(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, 0001822565-2022-02660-1, 0001822565-2022-02661-1, 0001822565-2022-02662-1, 0001822565-2022-02663-1.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.
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