MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL FEMUR CEMENTED SIZE 6 RIGHT MEDIAL; PROSTHESIS, KNEE

Catalog Number	42558000602
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 42528200708 - partial articular surface - 63784873.42538000702 - partial tibial component - 63720352.Unknown palacos with gentamycin.No devices or photograph were received; therefore the condition of the components is unknown.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records provided state that patient was revised due to metal allergy (nickel allergy), pain and inflammation.It was reported that patient was revised due to allergic reaction, hence the root cause can be attributed towards patient condition.This complaint is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a clinical study patient underwent a right knee tka approximately two years ago.Subsequently the patient had a revision after experiencing pain and inflammation due to a metal allergy.

• Brand Name: PERSONA PARTIAL FEMUR CEMENTED SIZE 6 RIGHT 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: 23425747
• Report Number: 0001825034-2025-03413
• Device Sequence Number: 12832319
• Product Code: HSX
• UDI-Device Identifier: 00880304808577
• UDI-Public: (01)00880304808577(17)270831(10)63760789
• Combination Product (Y/N): N
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 42558000602
• Device Lot Number: 63760789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2017
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White