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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen fluted stem extension 13mm x 175mm catalog #: 00598801614 lot #: 64124274, nexgen sharp fluted stem extension 12mm x 120mm catalog #: 00598801512 lot #: 64600788, nexgen rotating hinge knee stemmed tibial plate size 6 catalog #: 00588000600 lot #: 63987943, nexgen rotating hinge knee articular surface f 17mm catalog #: 00588006017 lot #: 64345163.The complainant has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.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 underwent a right knee arthroplasty revision to address femoral hinge fracture approximately three (3) years post-operatively.Attempts have been made; however, no additional information is available.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address femoral hinge fracture and instability approximately three (3) years post-operatively.Revision operative notes noted that the femoral and tibial components were stable.However, it was immediately apparent that the threaded portion from the bolt that threaded through the poly into the tibial component had broken off from the hinge component.The hinge component and all polyethylene and fractured pieces were able to be removed from the intra-articular space.The joint was copiously irrigated and new hinge components were placed without complication.No intraoperative complications were noted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4, b4, b5, b6, b7, g3, g6, h2, h6, h11.
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, g3, g6, h2, h3, h6, h11.H6 - component code - proposed code is mechanical femur (g04) visual examination of the picture provided identified signs of use, fractured fragments and bio debris on the surface.Medical records provided confirmed the patient was revised for failure of the hinge component and implant fracture.The device history records were reviewed and no discrepancies were identified.Per the lifestyle habits and considerations for the reported device, implants replace damaged cartilage/bone, but do not have the same characteristics as normal, healthy cartilage/bone.Implants can break or be damaged as a result of excessive forces or trauma.The surgeon should inform the patient of the limitations of the implant and the impact to the patient's lifestyle.Premature failure of implants via loosening, fracture, dislocation, subluxation and/or wear are more likely to occur when patients have unrealistic functional expectations and conduct excessive or unusual movement, are overweight, or when a patient fails to follow required rehabilitation.The surgeon should inform the patient of postoperative restrictions, the acceptable level of physical activity that can be performed and how a patient's lifestyle may be impacted.The root cause is attributed to patient noncompliance and failure to follow instructions.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT RIGHT SIZE F
• 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: 20678802
• Report Number: 0001822565-2024-03563
• Device Sequence Number: 12570212
• Product Code: KRO
• UDI-Device Identifier: 00889024199170
• UDI-Public: (01)00889024199170(17)230228(10)63844172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2025

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588001602
• Device Lot Number: 63844172
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 01/23/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/12/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 118 KG