MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. PERSONA TIB POR 0 DEG SPK KEL C RT; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented

Catalog Number	42535006402
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent an initial knee arthroplasty on an unknown date.Subsequently, the patient was revised due to tibial loosening.It was noted it appears clinically as fibrous in growth.
Additional Manufacturer Narrative
(b)(4).D10 concomitant products: 42522100310 - articular surface mc - 64843081.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 TIB POR 0 DEG SPK KEL C RT
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented
• Manufacturer (Section D): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50116477
• Report Number: 3007963827-2026-00339
• Device Sequence Number: 10032640
• Product Code: JWH
• UDI-Device Identifier: 00889024631892
• UDI-Public: (01)00889024631892(17)340813(10)66656269
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/03/2026

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: 42535006402
• Device Lot Number: 66656269
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female