MAUDE Adverse Event Report: Zimmer Manufacturing B.V. PERSONA ALL POLY PATELLA CEMENTED 35 MM DIAMETER; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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); Tendinopathy (4887)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient in a clinical study underwent an initial left total knee arthroplasty and subsequently required a cortisone injection and topical cream for iliotibial band tenderness approximately 3 months post-implantation.The patient symptoms resolved approximately 1 month later.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42502607401, psn fem cr cmt ccr std sz12, 67171727, 42532008301, psn tib stm 5 deg sz h l, 67434680, 42512101012, psn mc ve asf l 12mm 12/gh , 65432905, psn mc ve asf l 12mm 12/gh.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: PERSONA ALL POLY PATELLA CEMENTED 35 MM DIAMETER
• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
• Manufacturer (Section D): Zimmer Manufacturing B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): Zimmer Manufacturing B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50310427
• Report Number: 0002648920-2026-00143
• Device Sequence Number: 8770434
• Product Code: MBH
• UDI-Device Identifier: 00889024247642
• UDI-Public: (01)00889024247642(17)301106(10)67605739
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/15/2026

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: 42540000035
• Device Lot Number: 67605739
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 215 LB
• Patient Race: White