MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a knee revision surgery four years, six months post implantation due to an oversized femoral component.Also noted was subsidence and insufficiency on the lateral side under the tibial plate from the initial surgery with overhang noted in the primary tibial component and cyst under the lateral side of the tibial component.The patient complained of lateral and anterior knee pain.Attempts have been made and no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted additional associated products: 00595001705 cr flex pre-fem sz g lt minus, lot#: 63955319.
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/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.H6-component code- suggested code: mechanical (g04) - femur.X-rays were provided and reviewed by a health care professional.They state that the left knee demonstrates a total knee arthroplasty without a patellar component.There is no significant radiolucency along the femoral or tibial components, which do not appear loose.However, there is a valgus alignment of the knee with possible subsidence of the lateral tibial component.Additionally, moderate joint effusion and distal quadriceps enthesopathic changes are noted.The femoral component does not appear oversized, and no definitive evidence of tibial loosening was identified.Operative notes provided and reviewed state that the patient underwent a left total knee arthroplasty and was revised on 4 years, 6 months later, due to complications.These included an oversized femoral component, tibial loosening, subsidence and insufficiency on the lateral side of the tibial plate, overhang of the primary tibial component, and the presence of a cyst under the lateral side of the tibial component.The patient reported lateral and anterior knee pain, and the event was deemed a serious injury, necessitating surgical intervention.X-rays confirmed subsidence of tib tray.Operative notes confirmed loosening of tib tray.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 STEMMED TIBIAL COMPONENT PRECOAT SIZE 7
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20453496
• Report Number: 0002648920-2024-00321
• Device Sequence Number: 15205639
• Product Code: JWH
• UDI-Device Identifier: 00889024217621
• UDI-Public: (01)00889024217621(17)280930(10)64175619
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 00598005701
• Device Lot Number: 64175619
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 97 KG