MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN DISTAL FEMORAL AUGMENT BLOCK PRECOAT MAY BE USED WITH POSTERIOR; PROSTHESIS, KNEE

Catalog Number	00599003610
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.Visual examination of the provided intraoperative photo identified that a hinged total knee implant is in place.The femoral component appears to show signs of use and biological debris.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.Infection: the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.Loosening: a definitive root cause cannot be determined.This complaint cannot be 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 the patient underwent a left initial knee arthroplasty on an unknown date.Subsequently, the patient was revised due to recurring infection.It was noted that the patient appeared to have femoral loosening and would have required distal femoral replacement but was unavailable.

• Brand Name: NEXGEN DISTAL FEMORAL AUGMENT BLOCK PRECOAT MAY BE USED WITH POSTERIOR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22071637
• Report Number: 0001822565-2025-01517
• Device Sequence Number: 18318621
• Product Code: JWH
• UDI-Device Identifier: 00889024224186
• UDI-Public: (01)00889024224186(17)300331(10)64669837
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/21/2025

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: 00599003610
• Device Lot Number: 64669837
• 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: 05/08/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 85 KG