MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN RIGHT SIZE D CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00588001402
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Aseptic loosening (4883)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 00599003410 - distal femoral augment block - 64632239.00598801013 - straight stem extension - 65813061.00598801215 - straight stem extension - 65957211.00588000310 - tibial full block augment - 66028552.00588000300 - tibial component - 66134976.00588004014 - articular surface with hinge post - 66141876.42540200029 - patella - 66187800.00599003410 - distal femoral augment block - 00599003410.66022663 - palacos - 67211312.66022663 - palacos - 67211312.66022663 - palacos - 66941279.G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient underwent a revision approximately 17 months post implantation due to patient fall.Femoral fracture and femoral loosening was noted.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h4; h6.The reported event could not be confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.
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; g3; g6; h1; h2; h6; h11.The reported event could not be confirmed due to lack of product/information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.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 RIGHT SIZE D CEMENTED OPTION FEMORAL 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: 23061933
• Report Number: 0001822565-2025-03429
• Device Sequence Number: 13213654
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

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: 00588001402
• Device Lot Number: 66195501
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 06/11/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/28/2025; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female