MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA® VIVACIT-E; PROSTHESIS, KNEE,

Catalog Number	42522100410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was patient underwent a manipulation under anesthesia approximately one month post implementation due to loss of range of motion and pain.Patient continues to be dissatisfied with pain level.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10: 42502006202 67391589 psn fem cr cmt ccr nrw sz 7 r.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.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h6 the following was corrected: h4, h6 component code review of the reported event by a health care professional found: arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.Rheumatoid arthritis (ra) is a progressive chronic autoimmune condition causing stiffness and joint pain for which there is no cure.In the first stage of ra the body mistakenly attacks its own joint tissue.In stage 2 the joint begins to swell until ultimately at stage 4 there is essentially no joint remaining as it becomes fused.Progression isn't necessarily inevitable but patients need to ensure they follow their treatment plan and doctor's recommendations to prevent it and whatever joint damage has already occurred can't be reversed.Complex regional pain syndrome (crps) is associated with ra due to chronic pain and inflammation from the disease.Treatment consists of long term pain and anti-inflammatory medications.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.This device is used for treatment.This is a limited investigation.The device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is not confirmed.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.

• Brand Name: PERSONA® VIVACIT-E
• Common Device Name: PROSTHESIS, KNEE,
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; zimmer orthopaedic mfg. ltd.; building no 2 east park; shannon, county clare
• MDR Report Key: 24209036
• Report Number: 0001822565-2026-00322
• Device Sequence Number: 9625061
• Product Code: MBH
• UDI-Device Identifier: 00889024468092
• UDI-Public: (01)00889024468092(17)300423(10)67291626
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42522100410
• Device Lot Number: 67291626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female