MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PSN PK CMT FEM LM SZ 3; PROSTHESIS, KNEE

Catalog Number	42558000301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant medical products: 42518200608 - articular surface - 63667578.42538000601 - tibial component - 63614524.Unknown palacos cement.H6: component code: mechanical (g04) - femur.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient had a left unicompartmental knee arthroplasty.Approximately 2 years and 8 months post implantation, bilateral knee pain was reported, and a cortisone injection was administered to the study knee.All products remain implanted.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient had a left unicompartmental knee arthroplasty.Approximately 6 years post implantation, the patient reported knee pain and was administered a cortisone injection to the study knee.Subsequently, the patient continues with knee pain due to chondromalacia of patella.All products remain implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h11 an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient had a left unicompartmental knee arthroplasty.Approximately 6 years post implantation, the patient reported knee pain and was administered a cortisone injection to the study knee.Subsequently, the patient continues to have pain in the left knee due to osteoarthritis.Multiple cortisone injections have been provided.All products remain implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11 product has not been returned.No product evaluation was able to be completed.The root cause of the reported event is not device related.Disease progression of osteoarthritis can continue in native bone structures as a patient continues to age.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patient¿s risk for progressive osteoarthritis.Additionally, females have an inherent risk.Partial knee replacement is done to decrease pain, and increase flexibility, mobility and overall improve quality of life, as this is one of the least invasive approaches.Patients with disease progression of osteoarthritis in the affected joint develop knee pain and decrease in joint flexibility.As osteoarthritis progresses a loss of cartilage in the previously unaffected area of the knee has deteriorated to a point in which the patient and doctor may elect to provide steroid injections to reduce the pain and inflammation or even convert to a full-knee replacement to alleviate symptoms.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA PSN PK CMT FEM LM SZ 3
• 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 ; 5745260384
• MDR Report Key: 22372707
• Report Number: 0001825034-2025-01925
• Device Sequence Number: 7972037
• Product Code: HSX
• UDI-Device Identifier: 00880304808461
• UDI-Public: (01)00880304808461(17)270331(10)63642440
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/08/2025

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: 42558000301
• Device Lot Number: 63642440
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 08/06/2025; 10/06/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/11/2025; 08/26/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: American Indian Or Alaskan Native