MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC 2.9MM; SPORTS MED IMPLANTS

Model Number N/A

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

Patient Problem Stroke/CVA (1770)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 110010384, toggleloc 2.9mm, lot # 207280r.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.A medcial investigation was done and it was found that 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 hypercoagulants 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.A definitive root cause could not be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02105 h3 other text : remains implanted.

Event Description

It was reported a patient underwent a right bicep tenodesis approximately 2 years ago.Subsequently, a month afterwards, the patient experienced a stroke and went through stroke rehab.Treatment is unknown.During the visit about 4 months ago, the patient was progressing well and reported regularly participating in active events.Attempts have been made and there is no further information at this time.

• Brand Name: TOGGLELOC 2.9MM
• Type of Device: SPORTS MED IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17712344
• MDR Text Key: 322979966
• Report Number: 0001825034-2023-02104
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00880304812864
• UDI-Public: (01)00880304812864(17)230121(10)868910R
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

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 Expiration Date: 01/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 110010384
• Device Lot Number: 868910R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2018
• 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
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 54 KG