MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ST PRC TIB PLT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6a : implant date : (b)(6) 2024.D10 : unknown - unknown articular surface - unknown, unknown - unknown femoral component - unknown.G2 : foreign country : the netherlands.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 knee surgery.Subsequently, the patient reported pain and x-rays suggested tibial loosening and the patient was revised approximately 9 months post-op due to tibial loosening.The tibial component and poly were both 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.D10: 00596404012 - articular surface size ef 12 mm height ''use with plate 5 - 66196128 00596401652 - femoral component option size f right compatible with lps-flex prolong - 66451899.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 all implants except the femoral component were revised and an initial patellar component was implanted.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 returned product identified signs of use (scratches, gouges) and bone cement remains.Dimensional analysis of the product determined that the product, where measured, was conforming.The device history record was reviewed and no discrepancies relevant to the reported event were found.Operative notes provided and reviewed by healthcare professionals state that a patient underwent a revision surgery due to tibial loosening.During the revision, the tibial component was identified as loose and was removed.No intraoperative complications were reported during the revision.X-rays were provided and reviewed by healthcare professionals.Pre-revision imaging revealed minimal contour deformity and lucency at the medial tibial tray, with a slight change in implant position.This shift was concerning for implant loosening.The bone quality in all images was mildly osteopenic.Evidence of tibial implant loosening was present in the later images.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 ST PRC TIB PLT 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: 20786853
• Report Number: 0001822565-2024-03718
• Device Sequence Number: 7809365
• Product Code: JWH
• UDI-Device Identifier: 00889024217614
• UDI-Public: (01)00889024217614(17)330510(10)J7505470
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 04/02/2025

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: 00598004702
• Device Lot Number: J7505470
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 04/02/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/12/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown