MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN RHK FEMORAL COMPONENT; PROSTHESIS KNEE

Catalog Number	00588001601
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure two months post implantation due to infection and loosening of femoral and articular surface prosthesis.No more information is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: segmental art surf sz f 14mm catalog#: 00585006014, lot#: 63644224.Prc agmt block dist sz f 5mm, catalog#: 00599003610, lot#: 64669837.Prc agmt block dist sz f 5mm, catalog#: 00599003610, lot#: 64174947.Stem implant 16mmx200mm, catalog#: 00598801116, lot#: 64116817.G2: australia.H6: mechanical (g04) - femur.H3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is not confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue.To monitor for trends.

• Brand Name: NEXGEN RHK 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: 22052549
• Report Number: 0001822565-2025-01465
• Device Sequence Number: 5355373
• Product Code: KRO
• UDI-Device Identifier: 00889024199163
• UDI-Public: (01)00889024199163(17)270825(10)65117229
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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
• Device Catalogue Number: 00588001601
• Device Lot Number: 65117229
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown