MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD NITRIDED; PROSTHESIS, KNEE

Catalog Number	42572606402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthrofibrosis (4885)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty completed.Approximately 3 months post-op, the patient experienced stiffness and limited range of motion.Subsequently, the patient underwent a manipulation under anesthesia and the patient's symptoms have reportedly improved.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42522000410 - psn asf cr 10mm ve r 3-9 cd - 66686648, 42532006702 - tibia cemented 5 degree stemmed right size d - 66844647, unknown - unknown simplex cement - unknown.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.Root cause of the reported event is not device related.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD NITRIDED
• Common Device Name: PROSTHESIS, KNEE
• 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 ; 5745260384
• MDR Report Key: 22936296
• Report Number: 0001822565-2025-03205
• Device Sequence Number: 9920030
• Product Code: JWH
• UDI-Device Identifier: 00889024576186
• UDI-Public: (01)00889024576186(17)341010(10)66808755
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 09/02/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42572606402
• Device Lot Number: 66808755
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: Black Or African American