MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL TIBIAL CONE, MEDIUM 36X31MM; PROSTHESIS, KNEE

Catalog Number	00545001336
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3: it was reported that symptom onset began may 2024.D10: concomitant medical product: lcck nexgen right size f cemented option femoral component: catalog #00599401692, lot #63712895.Nexgen distal femoral augment block size f 5mm: catalog#00599003610, lot#63245944, qty#(b)(4).Nexgen 17mm diameter 100mm length straight stem extension combined length 145mm: catalog #00598801017, lot #63641556.Nexgen size 5 precoat cemented stemmed anterior/posterior wedged tibial component: catalog #00598800500, lot #63548576.Nexgen 13mm diameter 30mm length cemented stem extension combined length 75mm: catalog #00598801713, lot #63739216.Lcck nexgen 10mm height size e, f with locking screw green articular surface: catalog #00599404010, lot #62531565.Nexgen all poly patella standard cemented size 35 mm diameter 9.0 mm thickness: catalog #00597206535, lot #63868924.Palacos rg 1x40 single bone cement: catalog#00111314001, lot#86694600, qty#(b)(4).The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was that a patient underwent a revision total knee arthroplasty.Subsequently, six (6) years and four (4) months post-implantation, the patient began experiencing swelling, pain, stiffness, instability, buckling, redness, difficulty walking, and a cracking sound/loud painful pops.Diagnostic imaging was performed and did not reveal loosening of the cemented components.All implants remain implanted and additional medical intervention has not been reported.
Additional Manufacturer Narrative
The following report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual examination of the provided picture identified a posterior view of a right knee.A vertical midline surgical scar is visible.The knee appears enlarged compared to the surrounding limb.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records provided and reviewed by a healthcare professional state that the patient underwent revision surgery in which all prior products were removed and a cemented system was implanted (including femoral, tibial, patellar components, stem extensions, and a tibial cone).Postoperatively, the patient initially reported improvement in stability and mobility, with good range of motion and strength, though intermittent pain, effusion, stiffness, and clicking/popping sensations were later documented throughout the following year.Dermatology also evaluated him for an itchy rash.Subsequently, beginning six (6) years post-implantation, the patient reported new and worsening symptoms including swelling, pain, stiffness, instability, buckling, redness, difficulty walking, and painful cracking or loud popping sounds in the right knee.The patient described warmth and unpredictable symptoms.Imaging did not show loosening of the implants, and all components remain in situ.The patient continues to experience these symptoms and has requested a recall check for the implanted system.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: TRABECULAR METAL TIBIAL CONE, MEDIUM 36X31MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22872485
• Report Number: 3005751028-2025-00009
• Device Sequence Number: 13334827
• Product Code: MBH
• UDI-Device Identifier: 00889024308275
• UDI-Public: (01)00889024308275(17)221031(10)63781592
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 00545001336
• Device Lot Number: 63781592
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• 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: Other
• Patient Sex: Male
• Patient Weight: 88 KG