MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN 14MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Catalog Number	00588005014
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Dislocation (2374)
Date of Event	12/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty.Approximately 8 months post-op, the patient was experiencing range of motions issues and was revised due to the hinge post extension backing out.It is unknown how the dislocation occurred.The surgeon repositioned the existing hinge post in order to minimize the impact on the patient.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00588001502 - right size e cemented option femoral component femoral plastic cap must be removed prior to implantation - 66403815.00588000600 - size 6 precoat cemented tibial component - 66662556.00598801012 - 12mm diameter 100mm length straight stem extension combined length 145mm - 65577135.00598801011 - 11mm diameter 100mm length straight stem extension combined length 145mm - 66378032.00625006525 - bone scr 6.5x25 self-tap - 66399111.00625006530 - bone screw self-tapping 6.5 mm dia.30 mm length - 66840114.00625006530 - bone screw self-tapping 6.5 mm dia.30 mm length - 66673245.00625006540 - bone screw self-tapping 6.5 mm dia.40 mm length - 66551898.G2 : foreign country : china.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual inspection of the provided images performed.Images were taken during the surgical procedure and show the devices whilst implanted in the patient's body.Unable to determine the item or lot number of the reported device or determine the extent of any wear, damage or dislocation present.As the physical product was not returned, further evaluation could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the extension post is disengaged and dislocated reportedly 8 months post-surgery.A definitive root cause cannot be determined.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
No further event information available at the time of this report.

• Brand Name: NEXGEN 14MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION
• 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: 24036456
• Report Number: 0001822565-2026-00134
• Device Sequence Number: 10482508
• Product Code: JWH
• UDI-Device Identifier: 00889024199378
• UDI-Public: (01)00889024199378(17)271218(10)65722660
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00588005014
• Device Lot Number: 65722660
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male