MAUDE Adverse Event Report: Zimmer Biomet, Inc. PSN REV FEM CMT CCR PLS SZ 9R; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Catalog Number	42504606612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hyperextension (4523); Swelling/ Edema (4577); Arthrofibrosis (4885)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient hyperextended the right knee and reported swelling and pain about three months post implantation.Approximately two and half year's post implantation the patient complained of moderate pain and refused x-rays.Three years and three months after the patient refused x-rays, a right open lysis of adhesions with possible lateral release and polyethylene exchange due to arthrofibrosis was ordered.No further information provided.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, b7, d2b, g1, g3, g6, h1, h2, h6, h10, and h11 corrected: a3a, e1, e2.

• Brand Name: PSN REV FEM CMT CCR PLS SZ 9R
• 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: 50792570
• Report Number: 0001822565-2026-03150
• Device Sequence Number: 21461547
• Product Code: JWH
• UDI-Device Identifier: 00889024562721
• UDI-Public: (01)00889024562721(17)310502(10)64998976
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/25/2026

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 Catalogue Number: 42504606612
• Device Lot Number: 64998976
• 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: 08/27/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 230 LB