MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN ARTICULAR SURFACE; PROSTHESIS, KNEE

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

Patient Problem Stroke/CVA (1770)

Event Date 09/03/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown nexgen rotating hinge knee femoral stem: catalog#ni, lot#ni; unknown nexgen rotating hinge knee femoral component: catalog#ni, lot#ni; unknown nexgen rotating hinge knee tibia gr 3: catalog#ni, lot#ni; unknown nexgen rotating hinge knee tibial stem 10x100: catalog#ni, lot#ni; unknown nexgen patella gr 35: catalog#ni, lot#ni; unknown cement: catalog#ni, lot#ni.Report source: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02848; 0001822565-2022-02849.The product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a revision knee procedure.Subsequently, three days post-implantation, the patient suffered a stroke and was admitted to intensive care.The patient outcome is unknown at the time of this report.Due diligence is in process for this complaint; to date no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h6; h10.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management that are outside the control of zimmer biomet and therefore the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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 at time of this report.

• Brand Name: UNKNOWN NEXGEN ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• 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: 15533493
• MDR Text Key: 301107004
• Report Number: 0001822565-2022-02850
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/18/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female