MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NEXGEN FEMORAL COMPONENT PRECOAT SIZE E LEFT; PROSTHESIS, KNEE

Catalog Number	00596001551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was further reported that the patient underwent an initial knee surgery.Approximately 10 years post-op, the patient suffered a fall of an unknown mechanism and went to the hospital where x-rays were performed.Imaging did not identify a fracture and the patient continued to walk on their knee.The patient then experienced continued pain and swelling and was subsequently revised due to a medial condyle femoral fracture.All components except the patella were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00594605001 - fluted stem mobile tibial component/precoat for cemented use only for export only not for distribution in the usa size 5 - (b)(6).00594705010 - lps-mobile articular surface use with lps/lps-flex 51 or 52 suffix femorals size e 10 mm height - (b)(6).Unknown - unknown patella - unknown.G2: foreign country: australia.H6: mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: NEXGEN FEMORAL COMPONENT PRECOAT SIZE E LEFT
• 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24887337
• Report Number: 3007963827-2026-00139
• Device Sequence Number: 19621378
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Expiration Date: 06/30/2025
• Device Catalogue Number: 00596001551
• Device Lot Number: 63091443
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male