MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report was previously submitted erroneously on january 26, 2024, under manufacturing report number 0001822565-2024-00269.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2024-00085, 0001822565-2024-00268, and 0002648920-2024-00088.D10 medical devices: nexgen femoral component option size d right catalog#: 00596401452 lot#: 63500879.Nexgen articular surface size cd 10 mm height catalog#: 00596403010 lot#: 64064365.Nexgen all poly patella standard cemented size 29 mm diameter catalog#: 00597206529 lot#: 63848510.Palacos bone cement catalog#: 66017569 lot#: 94514870.G2 foreign source: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 the patient underwent a right knee revision approximately three years post-implantation for an unknown reason.No additional patient consequences were reported.
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.Updated: b4, d6, g3, g6, h2, h3, h6, and h11.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: a1, a3, a4, b1, b4, b5, b7, d2, d6a, g1, g2, g3, g6, h1, h2, h6.
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately three years post-implantation due to developed pain, limp, posterior medial collapse and aseptic loosening of tibial baseplate.Attempts to obtain additional information have been made; however, no more is available.
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; h6; h10.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was experiencing increasing pain, limping, problems with walking and sleeping.Images concerned for posterior medial collapse.Revision operative notes noted the tibial component was found loose and minimal cement attached to baseplate.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 STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 3
• 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: 18981810
• Report Number: 0002648920-2024-00087
• Device Sequence Number: 6639123
• Product Code: JWH
• UDI-Device Identifier: 00889024218833
• UDI-Public: (01)00889024218833(17)290430(10)64386879
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2025

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 Model Number: N/A
• Device Catalogue Number: 00598603701
• Device Lot Number: 64386879
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 03/14/2025; 09/09/2025
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 09/10/2024; 04/08/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG