MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE H 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Embolism/Embolus (4438)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: partial tibial cemented size h right medial catalog # 42538000802, lot #: 64417509, partial femur cemented size 4 right medial catalog #: 42558000402, lot #: 64587380.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827 -2021 -00215, 3007963827 -2021 -00216.Investigation incomplete.

Event Description

It was reported that there was an initial right partial knee arthroplasty.Subsequently, the patient experienced a pulmonary embolism and was hospitalized overnight approximately 3 months post-implantation.No further complications were noted.At the next follow up visits, the patient reported slight pain, no problems, full range of motion, and remained very satisfied.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: it was reported the patient developed a pulmonary embolism three months postop.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 postoperative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.This patient was compliant with postoperative aspirin for dvt prophylaxis in the immediate postop period.However, three months postop, the patient developed a pe and was placed on a stronger blood thinner which resolved the complication.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 PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE H 10 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• 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: 12540181
• MDR Text Key: 273569612
• Report Number: 0001822565-2021-02754
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304818613
• UDI-Public: (01)00880304818613(17)240331(10)64266217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42528200810
• Device Lot Number: 64266217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White