MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. Persona TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous

Catalog Number	42532006701
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
Additional Manufacturer Narrative
C(b)(4) d10: 42532006701 - tibia cemented 5 degree stemmed left size d - (b)(6), 42502006001 - femur cemented cruciate retaining (cr) narrow left size 6 - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left knee surgery.Subsequently, the patient fell, fractured their fibula, and blew out their mcl and was revised approximately 4 years post-op.Attempts have been made and all available information has been provided.

• Brand Name: Persona TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D
• 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: 50919292
• Report Number: 3007963827-2026-00441
• Device Sequence Number: 5330594
• Product Code: MBH
• UDI-Device Identifier: 00889024471030
• UDI-Public: (01)00889024471030(17)320419(10)65342091
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• 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 Catalogue Number: 42532006701
• Device Lot Number: 65342091
• 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: 05/04/2022
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 223 LB