MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E; PROSTHESIS, KNEE

Catalog Number	42532007102
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Impingement (4834); Aseptic loosening (4883)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2- australia.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.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 that a patient was revised approximately two years eight months post implantation due to tibial loosening leading to anterior-medial tibial wall impingement of keel.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11 corrected: d4 (udi); h4 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: thin radiolucent lines around the tibial stem that can be seen with mechanical loosening or infection.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.This complaint is not confirmed.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: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 22911399
• Report Number: 3007963827-2025-00338
• Device Sequence Number: 9130695
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: (01)00889024471061(17)320802(10)65433815
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Catalogue Number: 42532007102
• Device Lot Number: 65433815
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female