MAUDE Adverse Event Report: Zimmer Biomet, Inc. PERSONA Partial Femur Cemented Size 3 Left Medial; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a clinical study that the patient experienced moderate to severe knee pain and stiffness following an initial left partial knee arthroplasty.This was mentioned at follow-up visits through approximately five years post-implantation, symptoms were managed with acetaminophen and nonsteroidal anti-inflammatory drugs.The implants remained in place without further intervention.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Cmp-1058330 d10: 42538000401, ppk tibia, 63534512, 42518200408, ppk surface, 63424640 h6: mechanical (g04) - femur 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 Partial Femur Cemented Size 3 Left Medial
• Common Device Name: Prosthesis, Knee
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50332428
• Report Number: 0001825034-2026-02431
• Device Sequence Number: 5483343
• Product Code: HSX
• UDI-Device Identifier: 00880304808461
• UDI-Public: (01)00880304808461(17)270131(10)63461852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 42558000301
• Device Lot Number: 63461852
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2017
• 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: Other
• Patient Sex: Female
• Patient Weight: 164 LB
• Patient Race: Black Or African American