MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR CEMENTED STANDARD RIGHT SIZE 9; PROSTHESIS, KNEE

Catalog Number	42504606602
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee surgery on an unknown date.Subsequently, the patient was revised due to loosening.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown prk articular surface - unknown.Unknown - unknown prk tibial component - unknown.G2: foreign country: australia.H6: 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.
Event or Problem Description
It was further reported that the patient underwent a right knee surgery and approximately 2 months post-op, the patient was revised due to pain and femoral loosening.All components were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; a3; b4; b5; d1; d2; d4; d6a; d6b; d10; g1; g3; g4; g6; h1; h2; h4; h6.D10: 42522400710 - articular surface fixed bearing posterior stabilized (ps) right 10 mm height - 67052398.42542007502 - tibia fixed cemented right size f stem extension use required - 66367116.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event cannot be confirmed.Visual examination of the provided picture identified three explanted components: a femoral component, a polyethylene articular surface, and a tibial baseplate.All components show signs of use such as biological debris and blood.The device history record was reviewed and no discrepancies relevant to the reported event were found.X-rays were provided and reviewed by a healthcare professional.Review of the x-rays state that the component fixation is limited by poor image quality however there is no gross evidence of femoral or tibial component loosening.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA FEMUR CEMENTED STANDARD RIGHT SIZE 9
• 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: 22107778
• Report Number: 0001822565-2025-01600
• Device Sequence Number: 20613633
• Product Code: JWH
• UDI-Device Identifier: 00889024562585
• UDI-Public: (01)00889024562585(17)330724(10)65968844
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42504606602
• Device Lot Number: 65968844
• 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: 05/10/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 08/06/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male