MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL FEMUR CEMENTED SIZE 5 LEFT MEDIAL; PROSTHESIS, KNEE

Catalog Number	42558000501
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: additional associated products ------------------------------------------------ 42518200608 partial articular surface left medial size f 8 mm lot# 63726856.42538000601 partial tibial cemented size f left medial lot# 63661670.G2:austria 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.
Event or Problem Description
It was reported that as part of a study, the study site reported femoral loosening in zone 4/5 for the implant.Patient experiencing moderate pain at medial joint line, taking occasional nsaids, rom at 130 degrees, limping when walking because of knee.The event is declared as 'unrelated' to the device, and is tolerated.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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, h11.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 reported 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: femoral loosening in zone 4/5 ppk implant; no revision planned patient does not want to undergo another surgery; -- moderate pain at medial joint line, taking occasional nsaids, rom 0-130, limping when walking.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left knee medial compartment arthroplasty.The femoral component is not centered above the tibial component and rather is positioned medially relative to the tibial component placing greater stress on the medial inner margin of medial bearing/medial tibial plateau.This positioning along with slight excessive posterior slope of the tibial component may potentially contribute to patient's symptoms of "pain at medial joint line".At the posterior femoral component, very thin radiolucency with parallel sclerotic line is present which may indicate fibrous tissue and is not specific for loosening; however, warrants assessment of stability.Complaint is not confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA PARTIAL FEMUR CEMENTED SIZE 5 LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22644106
• Report Number: 0001825034-2025-02304
• Device Sequence Number: 8653915
• Product Code: HSX
• UDI-Device Identifier: 00880304808485
• UDI-Public: (01)00880304808485(17)270930(10)63760852
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: Lay User/Patient
• Device Catalogue Number: 42558000501
• Device Lot Number: 63760852
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male