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

Catalog Number	42530006402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3: exact event date is unknown however is reported to have occurred between (b)(6) 2024 and (b)(6) 2024.D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.G2: foreign: australia.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in will process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient underwent a revision total knee procedure.Subsequently, within six (6) days post-implantation, it was reported that the patient experienced a blood clot in the leg.Additional intervention has not been reported and patient outcome is currently unknown.Due diligence is in progress for this event; to date no additional information has been reported.
Event or Problem Description
It was reported that a patient underwent an initial total knee procedure.Subsequently, within six (6) days post-implantation, it was reported that the patient began to experience pain and swelling in the leg.An ultrasound confirmed the presence of a blood clot.Additional medication was prescribed to reduce the swelling and the patient is reported to have fully recovered.It was reported that all available information has been provided.
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; h10; h11.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b2; b4; b5; d1; d2; d4; d10; g3; g4; h2; h4; h11.D10: medical product: femur trabecular metal cruciate retaining (cr) standard porous: catalog#42502806002, lot#65781924; articular surface medial congruent (mc) right 13 mm height: catalog#42522100413, lot#66566444.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
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.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.As there are multiple factors that may contribute to dvt that are outside the control of zimmer biomet, investigation results concluded that the root cause of the reported event is attributed to non-device related factors.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.

• Brand Name: PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED RIGHT SIZE C
• 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: 20156301
• Report Number: 0001822565-2024-02878
• Device Sequence Number: 18241829
• Product Code: MBH
• UDI-Device Identifier: 00889024510524
• UDI-Public: (01)00889024510524(17)330208(10)65754987
• 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
• 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,Followup
• Report Date (Section B): 11/25/2024

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: Health Professional
• Device Catalogue Number: 42530006402
• Device Lot Number: 65754987
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/15/2024; 11/20/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/14/2024; 10/30/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Prefer Not To Disclose