MAUDE Adverse Event Report: Zimmer Biomet, Inc. Persona FEM CR PPS CCR STD SZ9 R; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented

Catalog Number	42508606602
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Aseptic loosening (4883)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.Subsequently, the patient was revised due to a quad tendon repair approximately 7 months post-op.During the revision, the surgeon examined the knee and the femoral component appeared to be loose.The surgeon tapped the femoral component off with little to no ingrowth in the implant.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).D6a: implant date: (b)(6)2025.D10: unknown - unknown articular surface - unknown.Unknown - unknown tibial component - unknown.H6: mechanical (g04) - femur.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 FEM CR PPS CCR STD SZ9 R
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented
• 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: 50155629
• Report Number: 0001822565-2026-02778
• Device Sequence Number: 9261145
• Product Code: JWH
• UDI-Device Identifier: 00889024631342
• UDI-Public: (01)00889024631342(17)350131(10)66994087
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42508606602
• Device Lot Number: 66994087
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown