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

Catalog Number	00598603702
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Customer has indicated that the product is in process of being 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 patient underwent a right knee surgery.Approximately 6 years post-op, the patient presented to the office with knee pain and was subsequently revised due to tibial loosening.The non-augmentable tibial component was found to be grossly loose with no cement adhered to the surface.All available information has been provided.
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.The event cannot be confirmed.Visual inspection of the provided image performed.Image shows explanted femoral and tibial components both displaying residue on the surface.Unable to confirm item number and lot number from the image.As the affected product was not returned, a further assessment could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: (b)(4) - femoral component option for cemented use only size f right - (b)(6).(b)(4) - all poly patella standard cemented size 32 mm diameter 8.5 mm thickness - (b)(6).(b)(4) - articular surface size ef 10 mm height use with plate 3 - (b)(6).(b)(4) - cobalt g-hv bone cement 40gm - (b)(6).(b)(4) - intramedullary plug lge - (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that during the revision, the surgeon noted that the tibial component was grossly loose and there was no adhesion of bone cement to the tibial component but was well adhered to the underlying bone.Patella was well fixed therefore retained.All other components were revised without complications.All available information has been provided.
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.The event is confirmed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records confirmed aseptic loosening of the right tibial component.Femoral and patella components were well fixed but the tibial component was grossly loose.Femoral component and vast majority of underlying bone cement was removed.There was no adhesion of bone cement to the tibial component but was well adhered to the underlying bone.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
• 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: 21588194
• Report Number: 0001822565-2025-00596
• Device Sequence Number: 8868624
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)290923(10)J6637182
• 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: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/16/2025

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: 00598603702
• Device Lot Number: J6637182
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 04/10/2025; 06/10/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/28/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 91 KG