MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00596401652 - femoral component option size f right compatible with lps-flex prolong - 64453045; 00596404010 - articular surface size ef 10 mm height use with plate 5 - 64541093; 00597206535 - all poly petella standard cemented size 35 mm diameter 9.0 mm thickness - 64387691.G2 : foreign country : japan.Customer has indicated that the product will not 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 patient underwent an initial bilateral knee surgery.Approximately 4.5 years post-op, the patient reported experiencing pain and loosening of the right tibial component was found on x-ray.The patient is scheduled for a revision surgery.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 the patient was revised.Attempts have been made and 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: a2; b4; b5; b6; b7; d2; d10; g1; g3; g6; h1; h2; h6 d10: unknown - unknown cement - 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 had a bilateral knee arthroplasty.Subsequently, the patient reported right knee pain and noise.The patient had x-rays taken and it was reported that the patient needed a right knee revision.Approximately 4 years post-op, the patient was revised due to tibial loosening.During the revision there was a bone defect noted on the medial condyle of the tibia.The patella was found to be in stable condition and was retained.All other components were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event is confirmed.Visual examination of the provided pictures identified the explanted device with foreign material on the surface.As the device was not returned, further evaluations could not be performed.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 identified the following: during the revision, there were no signs of infection found, the femoral component was explanted.The tibial component was loose and easily removed and there was a bone defect in the medial condyle of the tibia.The patella was found to be relatively stable and was therefore retained.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total knee arthroplasty with tibial and possible patellar component loosening.Sizing is appropriate.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
• 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: 20775267
• Report Number: 0002648920-2024-00360
• Device Sequence Number: 12784468
• Product Code: JWH
• UDI-Device Identifier: 00889024218864
• UDI-Public: (01)00889024218864(17)290531(10)64425377
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 04/28/2025

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: 00598604702
• Device Lot Number: 64425377
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 03/22/2025; 04/25/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/10/2024; 04/02/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• 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; Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 140 KG