MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762)

Event Date 10/15/2020

Event Type  Death  

Event Description

It was reported that the patient underwent an orif and revision of the right hip approximately 4 months post a revision with unknown products.The patient suffered a periprosthetic right hip fracture with concurrent dislocation.A closed reduction was attempted and unsuccessful, and therefore scheduled for orif & revision.During the procedure, anesthesia was successfully induced and within a few minutes, the patient¿s blood pressure dropped, and he became tachycardic.The procedure was stopped, and the patient went into cardiac arrest.The patient expired the next day from bilateral pulmonary embolisms.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00714, 0001825034-2022-00716, 0001825034-2022-00717.

Manufacturer Narrative

Procedural related complications are influenced by the ¿type of surgery, patients pre-existing comorbid state, and perioperative management.¿ if a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism.Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.The patient had a fractured femur was manipulated to reduce the dislocated hip but was unsuccessful.The patient was then dislocated and fractured for 3 days prior to an open repair attempt.The legal document states that the patient began to deteriorate minutes after full induction of anesthesia which would likely be just prior to or at the time of incision.Dvts develop as a result of patient comorbid conditions and decreased mobility or bed rest.They often remain undetectable until breaking free and are released into the bloodstream causing a lack of blood flow and oxygenation to the lungs (pulmonary embolism), in this case, leading to death.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

No further event information is available at the time of this report.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• 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: 13934965
• MDR Text Key: 288085166
• Report Number: 0001825034-2022-00715
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD.; UNKNOWN LINER.; UNKNOWN M2A SHELL.
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Sex: Male