MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN 15 X 30MM STUBBY STEM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-03674, 0001822565-2023-03675, and 0001822565-2023-03677.D10-medical product: unknown nexgen left f porous femoral.Unknown nexgen stemmed tibia.Unknown nexgen cr poly liner.G2- australia.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised approximately eight and a half years post implantation due to pain and radiographic cyst in the tibia.There is no additional information available.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Development of a cyst is a non-procedural or implant related event, that can occur at any time during a person¿s lifetime regardless of a surgical procedure or implant.Cysts are abnormal, closed sac or capsule like structures within tissue or bone that can present with varying size, shape, and consistency, such as gas, fluid, or semisolid.They can resolve without medical intervention, as the body simply absorbs them, or they can require medical intervention.Treatment can include needle aspiration, injection of steroids, as well as surgical removal.Symptoms a patient can experience include pain, swelling, alteration in sensation, limitation of joint mobility, and weakness.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN NEXGEN 15 X 30MM STUBBY STEM
• 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: 18363949
• MDR Text Key: 330990628
• Report Number: 0001822565-2023-03676
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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: 03/25/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/25/2024
• 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: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male