MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION FIXED TIBIAL COMPONENT SIZE F LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Crepitus (4893)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant devices - persona all poly patella 38mm, catalog#: 42540000038, lot#: 64561081, persona revision cemented standard femoral component size 11 left, catalog#: 42504607001, lot#: 64463084, persona revision stem 18mm x 135mm, catalog#: 42560113518, lot#: 64536729, persona distal femoral augment size 11 10mm, catalog#: 42556607010, lot#: 64363701, persona revision posterior femoral augment size 11 5mm, catalog#: 42556807005, lot#: 64363728, persona revision distal femoral augment size 11 10mm, catalog#: 42556607010, lot#: 64363701, persona revision trabecular metal femoral cone size large, catalog#: 42545001013, lot#: 64154149, persona posterior stabilizing articular surface 12mm left size 10-11 ef, catalog#: 42512600812, lot#: 64086729, persona revision offset stem 6mm x 15mm x 135mm, catalog#: 42560613515, lot#: 64530348, persona revision left medial half block size ef 10mm, catalog#: 42555805310, lot#: 64323688, persona revision left lateral half block size ef 10mm, catalog#: 42555805110, lot#: 64323684, persona revision trabecular metal tibial cone size medium, catalog#: 42545000512, lot#: 64189939.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient began experiencing continued pain and stiffness approximately five (5) years post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a1, b4, b5, b6, e1, e2, e3, g3, g6, h2, h6, h10, h11.The following sections were corrected: b2.
Event or Problem Description
It was reported that the patient began experiencing continued pain and stiffness approximately five (5) years post-operatively.Attempts have been made, however, no additional information is available.
Event or Problem Description
No further event information available at the time of this report.
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: h4.The product was evaluated through manufacturing review and medical records provided confirmed the reported event.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.

• Brand Name: PERSONA REVISION FIXED TIBIAL COMPONENT SIZE F LEFT
• 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: 23864882
• Report Number: 0001822565-2025-04689
• Device Sequence Number: 4450922
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42542007501
• Device Lot Number: 64296012
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 05/20/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/20/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 251 LB
• Patient Race: White