MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN OFFSET STEM EXTENSION 11MM X 100MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen stemmed precoat tibial component size 5 catalog #: 00598004701 lot #: 63413428, nexgen lcck option femoral component left size g catalog #: 00599401791 lot #: 63199707, nexgen lps-flex articular surface size gh 14mm catalog #: 00596204214 lot #: 62287661, nexgen standard cemented all poly patella size 32mm catalog #: 00597206532 lot #: 63467974, nexgen offset stem extension 17mm x 100mm catalog #: 00598801017 lot #: 62719565, nexgen precoat tibial block and screws size 5 5mm catalog #: 00598800526 lot #: 63528635.G2 - report source - foreign: event occurred in australia.H6 - component code - proposed code is mechanical (g04) - stem.Visual evaluation of a picture provided confirmed that the tibial component had fractured into two (2) pieces.Radiographic review could not confirm any evidence of loosening or instability.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.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address femoral loosening and medial tibial tray fracture with instability approximately eight (8) years post-operatively.No additional information is available.

• Brand Name: NEXGEN OFFSET STEM EXTENSION 11MM X 100MM
• 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: 22505703
• Report Number: 0001822565-2025-02506
• Device Sequence Number: 9247010
• Product Code: JWH
• UDI-Device Identifier: 00889024221444
• UDI-Public: (01)00889024221444(17)260131(10)63263438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598802011
• Device Lot Number: 63263438
• 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: 07/02/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2016
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 115 KG