MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 15MM DIAMETER 30MM LENGTH STRAIGHT STEM EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: rotating hinge knee size 5 precoat cemented tibial component catalog#: 00588000500 lot#: 64036627 18mm diameter 100mm length straight stem extension catalog#: 00598801018 lot#: 63002968 fem size f right catalog#: 00588011602 lot#: 64111549 17mm height size f articular surface with hinge post extension catalog#: 00588006017 lot#: 63700159 tibial block and screws precoat size 5 10 mm thickness catalog#: 00598800527 lot#: 64146426 g2 foreign source: australia 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.
Event or Problem Description
It was reported that patient underwent a right knee revision approximately five years post-implantation due to loosening of the tibial tray and stem.No additional patient consequences were reported.
Event or Problem Description
It was reported that patient underwent a right knee revision approximately five years post-implantation due to loosening.The entire construct was removed and replaced.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, g6, h2, and h11.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, h10, and h11.Proposed component code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is no fracture or evidence of implant loosening.Bone quality is osteopenic.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the issue could not be 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
No further event information available at the time of this report.

• Brand Name: NEXGEN 15MM DIAMETER 30MM LENGTH STRAIGHT STEM EXTENSION
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19931847
• Report Number: 0002648920-2024-00251
• Device Sequence Number: 8375260
• Product Code: JWH
• UDI-Device Identifier: 00889024221147
• UDI-Public: (01)00889024221147(17)280531(10)64063457
• 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: 2019
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 12/30/2024

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 Model Number: N/A
• Device Catalogue Number: 00598801215
• Device Lot Number: 64063457
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 12/27/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/23/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female