MAUDE Adverse Event Report: Zimmer Biomet, Inc. PERSONA Partial Femur Cemented Size 6 Left Medial; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Periprosthetic fracture (4902)
Date of Event	08/27/2026
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 underwent an open reduction internal fixation.The initial partial knee implants remained intact.About 2 years later, the patient swung his club while golfing and felt a pop in his knee which gave out.The surgeon told the patient at follow-up that he will need to be converted to a total knee.Further follow up with the patient indicates that a revision to a total knee arthroplasty was performed approximately a month after that.During the revision, bone filler was applied to a periprosthetic fracture.No intraop or further complications have been reported.The patient currently has no complaints with the new knee.No further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42518200612, ppk art surface, (b)(6).42538000601, ppk tibia, (b)(6).H6: proposed component code: mechanical (g04) - femur.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 Femur Cemented Size 6 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: 50946334
• Report Number: 0001825034-2026-02914
• Device Sequence Number: 10446249
• Product Code: HSX
• UDI-Device Identifier: 00880304808492
• 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
• Device Explanted Year: 2026
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42558000601
• Device Lot Number: 66046347
• 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: 10/18/2023
• 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