MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 6; PROSTHESIS, KNEE

Catalog Number	00598604702
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown articular surface 12mm: catalog #ni, lot #ni; unknown femoral component size g: catalog #ni, lot #ni; unknown patella component 38mm: catalog #ni, lot# ni.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately three (3) years and three (3) months post-implantation, the patient began to experience pain, swelling, and difficult ambulating.A diagnostic bone scan and labs revealed results consistent with loosening of the tibial component.A plan was set for a revision surgery at a later date.Due diligence is in progress for this event; to date no additional information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; g3; h2; h3; h4; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a healthcare professional.Primary operative notes found no intra operative complications.Revision operative notes confirm tibial component was grossly loose and there was no cement adhesion to the tibial component.Femoral and patella components were well fixed.A voluntary medical device recall including the reported device has been initiated due to the clinically and statistically significant higher overall revision rates when these tibial components are used with specific femoral components.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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
This follow-up report is being submitted to relay additional information.D10: medical product: femoral component option size g right compatible with lps-flex prolong: catalog#00596401752, lot#64459405; articular surface size gh 12 mm height "use with plate 5: catalog#00596404212, lot#64235211; all poly petella standard cemented size 38 mm diameter 9.5 mm thickness: catalog#00597206538, lot#65029358; cobalt g-hv bone cement 40gm: catalog#600-15-100, lot#105c1d0047.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately three (3) years and three (3) months post-implantation, the patient began to experience pain, swelling, instability, and difficult ambulating.A diagnostic bone scan and labs revealed results consistent with loosening of the tibial component.Subsequently, a revision surgery was performed two (2) months following the onset of symptoms.The tibial component was found grossly loose with no adhesion of the cement to the implant.The femoral component and patella were found to be well fixed however all components aside from the patella were revised.It was reported that all available information has been provided.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 6
• 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: 21479763
• Report Number: 0001822565-2025-00500
• Device Sequence Number: 8423856
• Product Code: JWH
• UDI-Device Identifier: 00889024218864
• UDI-Public: (01)00889024218864(17)300615(10)J6806029
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2025

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: Lay User/Patient
• Device Catalogue Number: 00598604702
• Device Lot Number: J6806029
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 06/11/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• 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: ZFA 2022-00240
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 124 KG