MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. Persona MC VE ASF L 14MM 4-5/CD; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous

Catalog Number	42512100314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Damage to Ligament(s) (1952)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury

• Brand Name: Persona MC VE ASF L 14MM 4-5/CD
• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous
• 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: 50919287
• Report Number: 3007963827-2026-00440
• Device Sequence Number: 5330591
• Product Code: MBH
• UDI-Device Identifier: 00889024468931
• UDI-Public: (01)00889024468931(17)250131(10)64548477
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 42512100314
• Device Lot Number: 64548477
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 223 LB