MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 4, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC FEMORAL SIZE 4, RIGHT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic cc tib insert size 4, 17mm (cat# 02-012-65-4017 / serial# (b)(4)); logic post.Aug.Block size 4, 5mm (cat# 02-010-06-0541 / serial# (b)(4)); lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(4)); logic stem ext 14mm x 40mm (cat# 02-012-60-1440 / serial# (b)(4)); tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)); cc distal fem augment sz 4, 5mm (cat# 208-05-04 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, surgeon revised the femoral components of a logic cc knee that he implanted on (b)(6) 2017.During the case surgeon noted incomplete fixation of the femoral device.There was no breakage of a device or surgical delay/prolongation.Patient was revised to exactech components.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation.
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 reason for the revision cannot be confirmed from the information provided but was likely the result of an insufficient bond between the femoral component and the bone.Potential contributions from patient-related conditions and/or cement issues to the reported failure cannot be confirmed from the reported information and the devices were not returned for evaluation.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the device 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, b3 (remove erroneously entered date on initial report-date of event unknown), d4 (expiration date), d8, d6b (remove erroneous entry from initial report- explant date unknown), e4: (remove erroneous entry from initial report), h6: clinical code, component code investigation findings, investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CC FEMORAL SIZE 4, 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15820614
• Report Number: 1038671-2022-01485
• Device Sequence Number: 11950536
• Product Code: JWH
• UDI-Device Identifier: 10885862265722
• UDI-Public: 10885862265722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 02/05/2026

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: 09/19/2021
• Device Model Number: LOGIC CC FEMORAL SIZE 4, RIGHT
• Device Catalogue Number: 02-010-06-0340
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 08/23/2023; 01/21/2026
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 09/25/2023; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG