MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEM CR PPS CCR STD SZ6 R; PROSTHESIS, KNEE

Catalog Number	42508606002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Radiolucent Lines (4848)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 8 months post implantation of a right total knee arthroplasty, the patient experienced severe pain, moderate problems walking, and clicking in the posterior aspect of the knee.Infection markers were negative, and the plan is to continue with conservative measures.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42536006702, psn tib np 0 deg kel d rt, lot # 66774856.42522100411, psn mc ve asf r 11mm 6-7/cd, lot # 66687470.42540000029, psn all poly pat ply 29mm, lot # 66792516.H6: proposed component code: mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h6, h10.The following section was corrected: h4.The reported event was confirmed via medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the medical records by a healthcare professional identified patient had dissatisfaction, experiencing severe pain and moderate problems walking.X-ray showed posterior medial lucency which has been present from initial surgery.No loosening of implant is appreciated, infection markers negative.Patient continues to suffer with pain during ambulation, along with numbness from knees to the toes.Revision surgery considered.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report.
Event or Problem Description
It has been further reported that the patient was revised approximately 14 months post implantation due to complaints of continued pain and x-ray identified radiolucency.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d6b, g3, h2, h6 d6b: explant date (b)(6) 2025.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA FEM CR PPS CCR STD SZ6 R
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23316294
• Report Number: 0001822565-2025-03770
• Device Sequence Number: 17426937
• Product Code: JWH
• UDI-Device Identifier: 00889024631281
• UDI-Public: (01)00889024631281(17)340613(10)66705012
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 07/21/2026

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: 42508606002
• Device Lot Number: 66705012
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 07/09/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/05/2026; 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2024
• 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: Other
• Patient Sex: Female
• Patient Weight: 155 LB
• Patient Race: White