MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE G; PROSTHESIS, KNEE

Catalog Number	42530007901
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D4: attempts have been made to gather all product identification information, and no further information has been provided.H3- customer has not indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised due to a delaminated tibial tray.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: a1, a3, b4, b5, d1, d2a, d2b, d4, d6a, g1, g3, g6, h1, h2, h4, h6, and h11.
Event or Problem Description
It was reported that a patient was revised due to a delaminated tibial tray which caused pain and discomfort.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: g4, h4.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 further event information available at the time of this report.

• Brand Name: PERSONA TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE G
• 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: 23846207
• Report Number: 0001822565-2025-04607
• Device Sequence Number: 15942339
• Product Code: MBH
• UDI-Device Identifier: 00889024510593
• UDI-Public: (01)00889024510593(17)340220(10)66497452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42530007901
• Device Lot Number: 66497452
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 04/08/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/12/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male