MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SEGMENTAL ART SURF SZ B 12MM; PROSTHESIS, KNEE

Catalog Number	00585002012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00585004202 - distal femoral xt component size b right use with polyethylene insert xt size b use with xt only for cemented use only in the u.S.A.- 66493183.00585004606 - segment with male/female taper 60 mm length - 63970663.42540200029 - all-poly patella cemented 29 mm diameter - 66915471.00585001296 - polyethylene insert xt size b use with distal femoral xt size b use with xt only - 66701071.00588000400 - size 4 precoat cemented tibial component - 66309614.00598801516 - 16mm diameter 75mm length sharp fluted stem extension combined length 120mm - 65492265.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.Approximately 6 months post-op, the patient presented with varus/valgus laxity, instability, and pain.X-ray findings noted apparent metal debris.Subsequently, the patient was revised.Upon opening the joint space, it was discovered that a piece of the metal bushing/post had broken off and the metal debris were metal hinge fragments.The poly was upsized and the femoral component was replaced.Attempts have been made and all available information has been provided.
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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual examination of the provided picture identified the segmental hinge post subcomponent is fractured and covered in foreign material.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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: knee arthroplasty with distal femoral replacement prosthesis-typically implanted to address significant bone loss resulting from oncology, trauma, and/or the salvage of previously failed arthroplasty.There is gross metal debris in the joint with fracture of the posterior tab to secure the polyethylene on the tibial base plate and angulation/malalignment of the metallic post concerning for post fracture.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.

• Brand Name: NEXGEN SEGMENTAL ART SURF SZ B 12MM
• 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: 22882745
• Report Number: 0001822565-2025-03051
• Device Sequence Number: 21048097
• Product Code: KRO
• UDI-Device Identifier: 00889024195684
• UDI-Public: (01)00889024195684(17)320310(10)66519749
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 00585002012
• Device Lot Number: 66519749
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 91 KG