MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED CEMENTED PRECOAT TIBIAL COMPONENT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient began experiencing a rash and blisters approximately four (4) months following left knee arthroplasty.The patient was treated with topical creams, however, the patient is concerned that the condition is an allergic reaction to the metals used in knee components.No additional patient consequences have been reported.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen option cemented femoral component size f left catalog #: 00599601651 lot #: 66840418, nexgen articular surface size ef 10mm catalog #: 00596404010 lot #: 67120274, palacos bone cement mv + g 1x40 catalog #: 66031983 lot #: 73991560.G2 - report source - foreign: event occurred in canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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: b4, g3, g6, h2, h3, h4, h6, h10, h11.The product was evaluated through manufacturing review and medical records provided confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: NEXGEN STEMMED CEMENTED PRECOAT TIBIAL COMPONENT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 23744918
• Report Number: 0001822565-2025-04400
• Device Sequence Number: 18260099
• Product Code: JWH
• UDI-Device Identifier: 00889024217607
• UDI-Public: (01)00889024217607(17)350225(10)J7915953
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 Model Number: N/A
• Device Catalogue Number: 00598004701
• Device Lot Number: J7915953
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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: Other
• Patient Sex: Male
• Patient Weight: 83 KG