MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIB POR 2 PEG SZ F L; PROSTHESIS, KNEE

Catalog Number	42530007501
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, eight (8) months post-implantation, the patient experienced sudden pain and underwent revision surgery due to subsidence of the tibial tray.The affected components were replaced and the femoral components remain intact.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: cruciate retaining left size 8 pps narrow femur: catalog#42508006401, lot # 65542157; articular surface medial congruent (mc) left 13 mm height: catalog # 42512100813, lot# 65050552; nexgen complete knee solution, trabecular metal standard primary patella: catalog# 00587806532, lot # 66053880.The product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Upon 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 were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographic images were provided and reviewed by a healthcare professional.Revision operative notes confirm patient's tibia had varus subsidence, and no loosening was noted.Femoral component not loose and not revised.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 TIB POR 2 PEG SZ F L
• 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: 21172616
• Report Number: 0001822565-2025-00147
• Device Sequence Number: 15826174
• Product Code: MBH
• UDI-Device Identifier: 00889024510579
• UDI-Public: (01)00889024510579(17)331205(10)66314684
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: Health Professional
• Device Catalogue Number: 42530007501
• Device Lot Number: 66314684
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG