MAUDE Adverse Event Report: EXACTECH, INC. TRU CC FEMORAL SIZE 3 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC STEM EXT 14MM X 40MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: - logic cc femoral size 3, right (cat# 02-010-06-0330 / serial# (b)(4).- logi logic tibia ps mod insrt sz 3 13mm (cat# 02-012-35-3013 / serial# (b)(4).- lgc tibial fit tray cem sz 3f / 3t (cat# 02-012-45-3030 / serial# (b)(4).- c stem ext 14mm x 80mm (cat# 02-012-60-1480 / serial# (b)(4).- logic fit/rbk augment 1/2 block sz 3, 5mm (cat# 02-012-50-3011 / serial# (b)(4).- logic post.Aug.Block size 3, 5mm (cat# 02-010-06-0531 / serial# (b)(4).- logic fit/rbk augment 1/2 block sz 3, 5mm (cat# 02-012-50-3011 / serial# (b)(4).- cc distal fem augment sz 3, 5mm (cat# 208-05-03 / serial# (b)(4).- metaphyseal tibial cone, ml32mm (cat# 02-012-66-2000 / serial# (b)(4).- tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six months post right tka, patient had a revision of the logic cc femoral construct due to loosening of the femoral components.It was revised using logic cc.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of both patient-related conditions and an insufficient bond between the femoral components and the bone which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and images of the explanted devices/pre-revision radiographs were not provided.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, d4, d8, g1, h4, h6: clinical code, component code, type of investigation, investigation conclusions.P class- the revision reported was likely the result of both patient-related conditions and an insufficient bond between the femoral components and the bone which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and images of the explanted devices/pre-revision radiographs were not provided.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 FEMORAL SIZE 3 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15393569
• Report Number: 1038671-2022-01082
• Device Sequence Number: 6463822
• Product Code: JWH
• UDI-Device Identifier: 10885862265715
• UDI-Public: 10885862265715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• 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,Followup
• Report Date (Section B): 02/17/2026

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: 09/14/2023
• Device Model Number: LOGIC STEM EXT 14MM X 40MM
• Device Catalogue Number: 02-010-06-0330
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 06/27/2023; 02/06/2026
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 07/15/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 47 KG