MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED TIBIA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Death (1802)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: persona femur cemented cruciate retaining (cr) catalog #: 42502605801, lot #: 64356382.Persona cr articular surface catalog #: 42511000410, lot #: 64457638.Persona all poly patella catalog # :42540000029, lot #: 64488661.The complainant has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2020-00048, 0002648920-2020-00086, 0002648920-2020-00087.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.During physical therapy, the patient experienced chest discomfort and collapsed.The patient required cpr, was transferred to an er and presumed to have a pulmonary embolism.The patient later expired after resuscitative efforts were unsuccessful.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device was not returned.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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.As the complaint indicated the patient may have developed a post-operative complication, it can be implied medical intervention was completed to treat the pe.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 available at the time of this report.

• Brand Name: PERSONA STEMMED TIBIA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9739072
• MDR Text Key: 180345131
• Report Number: 3007963827-2020-00049
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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: 42532006701
• Device Lot Number: 64402619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Death
• Patient Weight: 84