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

Catalog Number	42512600714
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient was revised approximately one and a half years post implantation due to instability.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h6; h10.The following section was corrected: d4, g4.Visual examination of the provided pictures showed the explanted items; no information was able to be obtained from the photos.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record identified no related 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 confirmed to be post revision.These were not reviewed by a health care professional.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint was 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA® VIVACIT-E
• Common Device Name: PROTHESIS, 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23188848
• Report Number: 3007963827-2025-00387
• Device Sequence Number: 9063129
• Product Code: MBH
• UDI-Device Identifier: 00889024238091
• UDI-Public: (01)00889024238091(17)251014(10)64822200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123459
• 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
• Report Date (Section B): 11/14/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/14/2025
• Device Catalogue Number: 42512600714
• Device Lot Number: 64822200
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2020
• 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: Unknown