MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED LEFT SIZE D; PROSTHESIS, KNEE

Catalog Number	42530006701
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records was not performed.Investigation results concluded that the root cause of the reported event is attributed to non-device related factors as the patient sustained an external trauma which caused the reported complication leading to revision surgery.There were no allegations against the device prior to the incident.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 at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h6; h11.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Approximately six (6) weeks post-implantation, the patient fell which resulted in loosening of the tibial component.Subsequently, the patient underwent revision surgery to replace the affected component without complication.
Additional Manufacturer Narrative
(b)(4).D10: medical product: articular surface medial congruent (mc) left 10 mm height: catalog#42512100410, lot#66680198; femur trabecular metal cruciate retaining (cr) narrow porous: catalog#42502206201, lot#66855503; all-poly patella cemented 29 mm diameter: catalog#42540200029, lot#66840236.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Approximately six (6) weeks post-implantation, the patient underwent revision surgery due to failure of the tibial component.Diligence is in progress for this event; to date no additional information has been reported.

• Brand Name: PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED LEFT SIZE D
• 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: 21415120
• Report Number: 0001822565-2025-00415
• Device Sequence Number: 18443616
• Product Code: MBH
• UDI-Device Identifier: 00889024510531
• UDI-Public: (01)00889024510531(17)340819(10)66908168
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/12/2025

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: 42530006701
• Device Lot Number: 66908168
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/02/2025; 05/20/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/31/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Female