MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 02-010-06-0340 - tru cc femoral size 4 right.(b)(6) 02-010-06-0541 - tru post.Aug.Size 4, 5mm.(b)(6) 02-012-64-1880 - tru fluted stm ext 18mm x 80mm blast.(b)(6) 02-012-65-4013 - tru cc tib insert size 4, 13mm.H3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that this patient's right knee was revised approximately 4 years post initial operation.Subsequently, the patient presented to surgeon with a loose tibia and patella.Surgeon removed a 38 patella, a size 4f/3t tibial tray and a 14 x 25 tibial stem.Also the liner was a size 4/13mm constrained ps insert.The surgeon revised to a the tibia to a 4f/3t with a 16 x 80 stem.The patella was revised to a 41mm three peg patella.A 32 tibial metaphyseal cone and a.4/19mm constrained insert.The patient is extremely active and does manual labor for work.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of insufficient bond between cement-implant interface and/or cement to bone interface leading to aseptic tibial and patellar loosening.The tibial tray being implanted for over 10 years could also have been a contributing factor in the reported loosening.The wear seen on the tibial insert may be the result of cement debris from the loosening components.However, this cannot be confirmed based on the information provided and potential contributions of user or patient-related considerations could not be assessed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRU CC TIB INSERT SIZE 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22097564
• Report Number: 1038671-2025-02153
• Device Sequence Number: 20944333
• Product Code: JWH
• UDI-Device Identifier: 10885862613493
• UDI-Public: 10885862613493
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2026
• Device Catalogue Number: 02-012-65-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 08/06/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 96 KG