MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE REGULAR CONSTRAINT; PROSTHESIS, KNEE

Catalog Number	90597002109
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11.No devices were received; therefore the condition of the components is unknown.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.The 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.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in the united kingdom.The device will not be returned for analysis, as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the implant would not sit and engage with the locking mechanism.Another implant was used to complete the procedure.There was no consequences or impact to the patient.It was reported that no further information is available.

• Brand Name: NEXGEN ARTICULAR SURFACE REGULAR CONSTRAINT
• 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: 21425789
• Report Number: 0001822565-2025-00434
• Device Sequence Number: 7781995
• Product Code: JWH
• UDI-Device Identifier: 00889024263499
• UDI-Public: (01)00889024263499(17)250430(10)63637592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 90597002109
• Device Lot Number: 63637592
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2017
• 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
• Patient Sex: Unknown