MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-44-2013
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported by legal, that this female patient's left knee was revised 5 years post op initial tka.Reason for the revision was not reported.No additional information.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2017.Approximately 5 years after the initial procedure the patient had a left knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2022: postoperative diagnosis: instability, left total knee replacement 2.Loosening left femoral implant.Findings: marked synovitis with a green hue.The knee was found to be unstable with 5-10 degrees of hyperextension and marked mid and full flexion instability.The polyethylene implant after being removed was inspected.There is no delamination or obvious polyethylene wear.The femoral implant was found to be grossly loose and literally came out by hand.It had totally debonded from the underlying cement.The tibial implant was found to be solidly fixed into the bone.No complications.The patient was transferred to the stretcher and wheeled to recovery in stable condition.
Additional Manufacturer Narrative
H3: investigation results: the revision reported was likely the result of femoral loosening and instability as stated in the operative notes.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and/or patient-related conditions.The instability may have been the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, improper positioning or malalignment of the prosthesis, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove from initial report-product information unknown), d8, g2 (initial report), h6: clinical codes, medical device problem codes, component code, types of investigation and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL COMPONENT
• 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15341082
• Report Number: 1038671-2022-01005
• Device Sequence Number: 4574893
• Product Code: JWH
• UDI-Device Identifier: 10885862173492
• UDI-Public: 10885862173492
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2026

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 Model Number: 02-012-44-2013
• Device Catalogue Number: 02-012-44-2013
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 09/08/2022; 09/26/2023; 01/20/2026
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/30/2022; 10/05/2023; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female