MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXT 3MM OFFSET SPLINED 14MM DIA 135MM L; PROSTHESIS, KNEE

Catalog Number	42560313514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had a hematoma evacuated approximately two weeks post procedure.A significant hematoma was noted, evacuated, and a drain placed.No intraoperative complications were noted.
Additional Manufacturer Narrative
(b)(4).Updated information was received for this complaint.The updated investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42504606212, persona femur cemented plus right size 7+, lot#: 65092679.42542007102, persona tibia fixed cemented right size e, lot#: 65619850.42522600710, persona articular surface bearing (cps) rt 10mm, lot#: 64125950.00597206535, nexgen all poly patella std size 35mm dia 9mm, lot#: 63932368.42556606210, persona femoral distal augment cemented size 7 10mm, lot#: 65755292.42556806205, persona femoral posterior augment cemented size 7 5mm, lot#: 65703519.42555805410, persona tibial augment half block right medial size ef 10mm, lot#: 64594695.42560113513, persona stem extension st splined 13 mm dia 135 mm l, lot#: 64989092.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.No product has not been returned.No product evaluation was able to be completed.Reported event is not related to device therefore, a compatibility review is not applicable.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.Root cause of the reported event is not device related.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA STEM EXT 3MM OFFSET SPLINED 14MM DIA 135MM 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: 21719913
• Report Number: 0001822565-2025-00813
• Device Sequence Number: 3862236
• Product Code: JWH
• UDI-Device Identifier: 00887868250040
• UDI-Public: (01)00887868250040(17)320517(10)65347348
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/06/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42560313514
• Device Lot Number: 65347348
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• 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
• Patient Weight: 82 KG