MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA® VIVACIT-E; PROSTHESIS, KNEE

Catalog Number	42522800710
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee polyethylene exchange approximately 20 months post-implantation due to a disengaged locking screw identified on radiograph.The team was notified following review of an x-ray.Intra-operatively, all implants were well fixed.The disengaged screw and the constrained condylar knee polyethylene insert were removed, and a cps polyethylene insert was implanted.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5; g3; h3; h4, h6 the following was updated: h6 component code - visual examination of the returned product identified the articular surface exhibits signs of implantation in the form of scratches.The lock down screw exhibits damage on both the hex end and threaded end.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.- review of the device history records identified no deviations or anomalies during manufacturing.- device is used for treatment.- the reported products were reviewed for compatibility with no issues noted.- review of complaint history found no additional related issues for this item and the reported part and lot combination.- radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total knee arthroplasty with dislodged locking screw for the polyethylene insert.- a definitive root cause cannot be determined.- no corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is 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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: PERSONA® VIVACIT-E
• Common Device Name: 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: 24114530
• Report Number: 0001822565-2026-00187
• Device Sequence Number: 9371706
• Product Code: JWH
• UDI-Device Identifier: 00889024555303
• UDI-Public: (01)00889024555303(17)250531(10)64709711
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 05/01/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 42522800710
• Device Lot Number: 64709711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male