MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TIBIAL COMPONENT STEM EXTENSION; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Failure of Implant (1924); Nerve Damage (1979); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Nexgen stem extension item # 00598801016, lot # 62548446.Tm femoral diaphyseal cone item # 00545001930, lot # 61854553.Nexgen constrained condylar (lcck) femoral component option item # 00599401691, lot # 62647371.Nexgen stem extension item # 00598801022, lot # 37214677.Nexgen articular surface item # 00599404014, lot # 62686510.Nexgen lcck tm tibial cone item # 00544705631, lot # 62319588.Palacos bone cement item # 00-1112-140-01, lot # 77274365.H3: customer has indicated that the product will not be returned because product location is unknown.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 patient underwent a revision procedure ten years post implantation due to pain, femoral component loosening, corrosion of implant, metal related pathology and reported loss of sensation in foot.Operative report noted that there was gross metallosis and corrosion on the tibial base plate.Report also noted metal debris within the articular space.The femoral component was grossly loose.All components were explanted, debrided joint of metallosis tissue/synovectomy.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, b7, d2, g1, g2, g3, g6, h1, h2, h10.G2: maude report # mw5163961.
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.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates the patient reported pain, instability, swelling, and drainage in their left knee, along with steroid injections.An mri confirmed aseptic loosening and nerve damage causing loss of sensation in half of the left foot due to knee failure and metallosis.A revision surgery addressed aseptic loosening, mechanical failure, and gross metallosis with corrosion at the implant interface and metal debris.All components were revised, the joint was debrided of metallosis tissue, a synovectomy was performed, and new components were implanted following an osteotomy.Soft tissue samples were negative for acute inflammation.The closure involved a pico wound vac and jp drain.The mri report indicates increased activity surrounding the left knee, particularly around the tibial and femoral components of a revised knee arthroplasty, suggesting complications with the revision.Additionally, there is intense uptake surrounding both the glenoid and humeral components of the right shoulder arthroplasty.The lower lumbar spine shows typical degenerative changes, and the soft tissue contours, kidneys, and urinary bladder appear unremarkable.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 TIBIAL COMPONENT STEM EXTENSION
• 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: 21149196
• Report Number: 0001822565-2025-00117
• Device Sequence Number: 18421461
• Product Code: JWH
• UDI-Device Identifier: 00889024220577
• UDI-Public: (01)00889024220577(17)240430(10)62672916
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2025

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00598800600
• Device Lot Number: 62672916
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 05/21/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/04/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2014
• 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 Sex: Male
• Patient Weight: 99 KG
• Patient Race: White