MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR CEMENTED PLUS LEFT SIZE 9+; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products(reported): 42560007514 persona stem extension tapered cemented 14mm dia +75mm l lot# 64911552.42556806605 persona femoral posterior augment cemented size 9, 9+ 5mm lot# 65085586.42556606610 persona femoral distal augment cemented size 9, 9+ 10mm lot# 64826713.42556606610 persona femoral distal augment cemented size 9, 9+ 10mm lot# 64664219.42542007501 persona tibia fixed cemented left size f lot# 64847567.42512800714 persona articular surface fixed bearing (cck) left 14mm lot# 64314279.42560007514 persona stem extension tapered cemented 14mm dia +75mm l lot# 64911552.
Event or Problem Description
It was reported a patient began to experience an increase in pain approximately 8 months post procedure.The patient was prescribed a medrol pack and an additional course of physical therapy.The pain improved but returned around 2 weeks later where it was presented over the lcl and a genicular block was recommended.All radiographic imaging displays implants in good position without gross failure or loosening and all implants remain in place.
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 information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.H6-component code- suggested code: mechanical (g04) femur.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: mild pain; no indication of loosening.This complaint has been confirmed by review of the provided medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 FEMUR CEMENTED PLUS LEFT SIZE 9+
• 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: 19567533
• Report Number: 0001822565-2024-02065
• Device Sequence Number: 17879623
• Product Code: JWH
• UDI-Device Identifier: 00889024119833
• UDI-Public: (01)00889024119833(17)300331(10)64693787
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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 Model Number: N/A
• Device Catalogue Number: 42504606611
• Device Lot Number: 64693787
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White