MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HYBRID GLENOID; SHOULDER PROSTHESIS/EXTREMITIES

Model Number N/A

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00693 and 0001825034-2022-00694.Medical products: item#: unknown, unknown humeral head; lot#: unknown, item#: unknown, unknown humeral stem; lot#: unknown.Source: sperling, john w, marigi, erick m, lenartowicz, karina a, jennewine, brenton, throckmorton, thomas w.(2022) clinical and radiographic outcomes of hybrid glenoid fixation with a central porous titanium post: analysis of 713 consecutive shoulders, journal of shoulder and elbow surgery.Https://doi.Org/10.1016/j.Jse.2021.12.033.It was reported that two patients experienced a stroke in an unknown time frame after initial total shoulder arthroplasty.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.A stroke is a "brain attack.It 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 (hemorrhagic) and ischemic stroke occurs when a blood vessel carrying blood to the brain is blocked by a blood clot (ischemic).Perioperative stroke involves different pathways.Thrombotic (ischemic) stroke can result from increased inflammation and hypercoagulability [blood clotting disorder], cardio embolic stroke can result from disease states such as atrial fibrillation [irregular heart beat], and tissue hypoxia [lack of oxygen] from anemia can result from the combination of anemia and beta-blockade.A perioperative stroke is a serious and rare complication that may occur when a patient undergoes a surgical procedure, requiring 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.

Event Description

It was reported in a journal article that a cerebrovascular accident (stroke) occurred postop.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN HYBRID GLENOID
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13939783
• MDR Text Key: 288135083
• Report Number: 0001825034-2022-00695
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Hospitalization