MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA VIVACIT-E MEDIAL CONGRUENT ARTICULAR SURFACE 10MM LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Insufficient Information (4580)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address infection and pain approximately ten (10) months post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address unknown complications approximately ten (10) months post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona cruciate retaining cemented standard femoral component left size 10mm catalog #: 42502606801 lot #: 66298320, persona cemented stemmed natural tibial component left size g catalog #: 42532007901 lot #: 66512138, persona cemented all poly patella 35mm catalog #: 42540200035 lot #: 66296659.G2 - report source - foreign: event occurred in australia.The complainant has not yet indicated whether the product will 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h6, h11.The following sections were corrected: h4.The reported event could not be confirmed as medical records were not provided.The device history records were not reviewed as the event was determined to be unrelated to the implanted device.Sterile certifications were reviewed and found to be conforming with no applicable deviations.The device was verified to have gone through acceptable sterilization processes following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors that may include hospital/surgical environment, provider-related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issue affecting implant safety or effectiveness, the implanted products are not identified as the source or contributing to the reported infection.The root cause was determined to be traced to non-device related factors.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 event information available at the time of this report.

• Brand Name: PERSONA VIVACIT-E MEDIAL CONGRUENT ARTICULAR SURFACE 10MM LEFT
• 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 ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22663139
• Report Number: 3007963827-2025-00295
• Device Sequence Number: 7626228
• Product Code: MBH
• UDI-Device Identifier: 00889024469372
• UDI-Public: (01)00889024469372(17)290126(10)66285461
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512100910
• Device Lot Number: 66285461
• 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: 07/12/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 10/09/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/20/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male