MAUDE Adverse Event Report: Zimmer Biomet, Inc. Persona 0 Degree Keeled Tibial Component Size G Right; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has experienced moderate to severe pain and difficulty with activities approximately one (1) year following a right knee arthroplasty.Patient was recommended to modify activities and shoe wear and to pursue physical therapy, deep tissue massage and weight loss.Attempts have been made, however, no additional information is available.
Event or Problem Description
It was reported that the patient has experienced moderate to severe pain and difficulty with activities approximately one (1) year following a right knee arthroplasty.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, b6, b7, g3, g6, h2, h10, h11.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona cemented standard femoral component size 12 right catalog #: 42500607402 lot #: 66089875, persona posterior stabilized articular surface 12mm right 10-12 gh catalog #: 42522401012 lot #: 65295283, persona cemented all-poly patella 38mm catalog #: 42540200038 lot #: 66030404.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.

• Brand Name: Persona 0 Degree Keeled Tibial Component Size G Right
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
• 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 ; +1(574)526-0384
• MDR Report Key: 50148105
• Report Number: 0001822565-2026-02771
• Device Sequence Number: 9407271
• Product Code: JWH
• UDI-Device Identifier: 00889024632158
• UDI-Public: (01)00889024632158(17)330722(10)65905953
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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 Model Number: N/A
• Device Catalogue Number: 42536007902
• Device Lot Number: 65905953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• 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: Other
• Patient Sex: Male
• Patient Weight: 249 LB
• Patient Race: White