MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 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 (b)(6) 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#2; 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#2.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.
Event or Problem Description
Upon receipt of additional information, it was determined that this initial report has been filed to the incorrect mfr.A corrected report will be sent to mfr 3005751028.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h6; h10 upon receipt of additional information, it was determined that this initial report has been filed to the incorrect mfr.A corrected report will be sent to mfr 3005751028.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.

• Brand Name: TRABECULAR METAL TIBIAL CONE, MEDIUM 36X31MM
• 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: 21632140
• Report Number: 0001822565-2025-00649
• Device Sequence Number: 7547468
• 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): 08/21/2025

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: 02/19/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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