MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 5; Prosthesis, Knee

Catalog Number	42502605802
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 that a patient underwent an initial right total knee arthroplasty.Two weeks following the initial physical therapy treatment, the patient began to experience a sudden onset of intense pain after waking up.Subsequently, the patient underwent two (2) additional rounds of physical therapy.Four (4) months post-implantation, the patient continues to have pain and decreased range of motion.Due diligence is in progress for this event; to date all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: persona articular surface fixed bearing uc right 12mm height: catalog#42522200412, lot#67620080; persona tibia cemented 5 degree stemmed right size c: catalog#42532006402, lot#67017716; persona all poly patella cemented 26mm diameter: catalog#42540000029, lot#67535801; biomet bc r 1x40 us: catalog#110035368, lot#au14be1202.H6: proposed component code: mechanical (g04) - femur.The device will not be returned for further evaluation as it remains implanted.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 5
• Common Device Name: Prosthesis, Knee
• 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: 50333312
• Report Number: 3007963827-2026-00368
• Device Sequence Number: 5431422
• Product Code: MBH
• UDI-Device Identifier: 00889024230323
• UDI-Public: (01)00889024230323(17)350724(10)67351018
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 42502605802
• Device Lot Number: 67351018
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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 narrative.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 157 LB