MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN FEM PS CMT CCR STD SZ 8 L; PROSTHESIS, KNEE

Catalog Number	42500606401
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10- medical product.Psn tib stm 5 deg sz f l, item# 42532007501, lot# 65568832.Psn asf ps 10mm ve l 6-9 ef, item# 42512400710, lot# 65543115.All poly pat ve 35 mm dia, item# 42540200035, lot# 65649316.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Proposed annex g code: mechanical (g04) - femur.
Event or Problem Description
It was reported that a patient is experiencing swelling and possible allergic reaction approximately two years seven months post implantation.The patient called stating he needs to know if his implant contains nickel as he has been found to be allergic to nickel.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, g1, g3, g6, h1, h2, h3, h6, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The ifu document (b)(4) en rev.C lists nickel as a material in the composition of the implant material and also under 'material precautions' states that "nickel, is classified as a skin sensitiser 1: sensitisation or allergic reaction to users and/or patients".The ifu states do not use in patients with suspected or confirmed metal sensitivity or allergy to the metals utilized in the manufacture of the subject device.The root cause can therefore be attributed to a failure to follow instructions.This complaint is not confirmed.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
It was reported that a patient is experiencing swelling and possible allergic reaction approximately two years seven months post implantation.The patient called stating he needs to know if his implant contains nickel as he has been found to be allergic to nickel and was advised that implant material composition could not be provided without specific product information.

• Brand Name: PSN FEM PS CMT CCR STD SZ 8 L
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23544401
• Report Number: 3007963827-2025-00454
• Device Sequence Number: 9322838
• Product Code: JWH
• UDI-Device Identifier: 00889024229235
• UDI-Public: (01)00889024229235(17)320909(10)65460096
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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 Catalogue Number: 42500606401
• Device Lot Number: 65460096
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 102 KG