MAUDE Adverse Event Report: Zimmer Biomet, Inc. PERSONA Partial Tibial Cemented Size F Left Medial; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Periprosthetic fracture (4902)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an initial left partial knee arthroplasty performed.Approximately 6-8 weeks postop, the patient was participating in physical therapy and felt a sudden pain with inability to walk.X-rays revealed a periprosthetic tibial fracture with implant subsidence.As a result, the patient underwent an open reduction internal fixation.The initial partial knee implants remained intact.No further details regarding the event are known at this time.
Additional Manufacturer Narrative
(b)(4) d10: 42558000601, ppk femur, (b)(6), 42518200612, ppk art surface, (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.

• Brand Name: PERSONA Partial Tibial Cemented Size F Left Medial
• Common Device Name: Prosthesis, Knee
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50946339
• Report Number: 0001825034-2026-02915
• Device Sequence Number: 16063844
• Product Code: HSX
• UDI-Device Identifier: 00880304812703
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: N/A
• Device Catalogue Number: 42538000601
• Device Lot Number: 65949115
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 200 LB