MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LEGACY PROLONG; KNEE PROSTHESIS

Catalog Number	00596203010
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown tibial component - unknown g2 foreign: india customer has indicated that the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the locking mechanism was not working and on closer inspection, the surgeon found the locking mechanism seemed damaged.This was noted after the surgeon tried to place the poly in the joint space after trialing was complete.No patient harm, no delay noted.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a3; g3; h2; h6 the following was corrected: h4 the product has not been returned at this time.Photographs of the reported device were provided however a detailed evaluation of the damage on device cannot be performed.-review of the device history records identified no related deviations or anomalies during manufacturing.-the articular surfaces used are compatible to be used with the tibial tray.-medical records were not provided.-root cause cannot be determined.-complaint cannot 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 information is 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, d9, g3, h2, h6.Visual examination of the returned articular surface device identified signs of insertion attempt with gouges and inserter tool marks present.The dovetail feature was flared and compressed.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: NEXGEN LEGACY PROLONG
• Common Device Name: KNEE PROSTHESIS
• 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: 22326988
• Report Number: 0001822565-2025-02106
• Device Sequence Number: 20939922
• Product Code: MBH
• UDI-Device Identifier: 00889024211018
• UDI-Public: (01)00889024211018(17)281001(10)66195947
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 04/22/2026

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 Catalogue Number: 00596203010
• Device Lot Number: 66195947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 04/22/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/22/2025; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: Female