MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC CR FEMORAL CEM, RIGHT, SZ 2
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 3625737 - 02-012-51-2013 - logic tib insert impl crc, sz 2, 13mm.4822337 - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.4920866 - 200-05-26 - inset patella 26mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 62 yo female patient, initial right knee implanted with recalled poly on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 3 months post the initial procedure.The patient returned to the surgeon¿s office with complaints of pain, swelling, instability, and dissatisfaction with their right tka.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient underwent a full knee revision to a competitor¿s revision knee implants.Exactech revision knee implants and equipment were not brought to the case.Only tibial poly implants and patellas were provided.It was noted that the femoral component was loose and was removed from the femoral bone.The tibia implant was fixed though, but without exactech revision metal femoral options at the procedure, the tibial component had to be removed for the competitor¿s knee revision to be implanted.A complete knee revision occurred using a competitor¿s knee revision system.There were no device breakages during the procedure.There was a 15-to-30-minute surgical delay because the full revision took longer than the intended poly swap.There were no adverse events to the patient as a result.The patient was last known to be in stable condition following the event.No x-rays were provided.No explanted devices are available for analysis.They were discarded by the facility.Device images were provided.No further information.
Event or Problem Description
Additional details from a legal short form and operative report.The short form indicated the patient suffered immense pain, loss of consortium, and loss of mobility.Pre-operative diagnosis-failed right total knee arthroplasty due to instability.Post-operative diagnosis-failed right total knee arthroplasty due to instability, probably right disease, and femoral component debonding.Once the surgeon entered the joint, there were a significant amount of synovial tissue consistent with poly wear disease.Significant poly wear observed on the weight bearing portion of the lateral condyle.The femoral component was debonded from the underlying bone, and the tibial component was in significant varus malalignment.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, h6 - clinical code, problem code, investigation type, findings, conclusion.The following sections were corrected: h6 - 1932 inflammation no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely due to prosthesis wear, instability, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, inclusion of the polyethylene in the recall, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The instability may have been caused by implant malalignment; however, this cannot be confirmed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR FEMORAL CEM, RIGHT, SZ 2
• 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 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18852269
• Report Number: 1038671-2024-00414
• Device Sequence Number: 7415387
• Product Code: JWH
• UDI-Device Identifier: 10885862158093
• UDI-Public: 10885862158093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: LOGIC CR FEMORAL CEM, RIGHT, SZ 2
• Device Catalogue Number: 02-010-03-0320
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/15/2024; 04/16/2025
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/18/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2017
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female