MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.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 the patient underwent revision surgery approximately 4 years post implantation due to tibial loosening.Attempts for additional information have been made and none has been provided.
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, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.This complaint cannot be confirmed.A definitive root cause cannot be determined.No new 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.
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, g4, g6, h1, h2, h6, h11.Additional information was received from the customer.A new investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent revision surgery approximately 4 years post implantation due to subsidence of tibial component.During the revision it was noted that the tibial component had subsided into extension varus, severe synovitis, and osteolysis.The femoral and tibial components were revised without complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.D10: 00596401652 femoral component option size f lot# 63868359 00596405112 articular surface size ef 12 mm lot# 63054214 110034355 refobacin bc r 1x40 us lot# 805bak0203 110034355 refobacin bc r 1x40 us lot# 805bak0203.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient presented with increased pain and a varus deformity, and workup confirmed complete failure of the tibial baseplate with subsidence into varus.The preoperative diagnosis was aseptic failure of the right knee.Surgery was performed under general anesthesia with an adductor canal block, and estimated blood loss was 400 ml.Intraoperatively, 50 ml of bloody fluid was aspirated, and severe polyethylene synovitis was observed without signs of infection.The tibial component had subsided into extension and varus, while the femoral component remained well fixed and aligned; however, cement was removed and the femur was explanted.Osteolysis was noted beneath the cement in the tibia.Trial implants showed excellent alignment, balance, and tracking, and final components were placed successfully.The wound was thoroughly irrigated, closed in layers, and a wound vac was applied.The patient was transferred to recovery in satisfactory condition with no intraoperative complications.This complaint can be confirmed based on the medical records provided.Root cause cannot be determined.A field action was initiated, and the device was implanted before the recall was initiated.Zimmer biomet is conducting a voluntary medical device recall related to tibial components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with other branded components as compared to other total knee arthroplasties in the united kingdom national joint registry (uk njr).No new 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS 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: 19531691
• Report Number: 0002648920-2024-00188
• Device Sequence Number: 12688951
• Product Code: JWH
• UDI-Device Identifier: 00889024218871
• UDI-Public: (01)00889024218871(17)280430(10)64021336
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 08/26/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00598605701
• Device Lot Number: 64021336
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 03/03/2025; 08/19/2025
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 11/21/2024; 03/27/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ZFA 2022-00240
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG