MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-03-0340
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 200-02-32 - three peg patella 32mm sn: (b)(6).02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t sn: (b)(6).02-012-47-4009 - logic cr tib insert std, sz 4, 9mm sn: (b)(6).
Event or Problem Description
As reported, approximately 10 years post op initial right tka, this 65 y/o female patient was revised due to loosening.Patient retuned to surgeons office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient underwent a complete knee revision to a competitors device.Longer surgery and a complete revision was necessary due to loose primary exactech implants.Devices are not returning - the implants were sent to the lab and legal at the hospital.Unable to obtain x-rays.Images attached.
Additional Manufacturer Narrative
The reason for the revision reported may be the result of the reported pain, swelling, and instability; these may have been caused by prosthesis wear, implant loosening, or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component and the tibial tray to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.The malalignment may have contributed to the loosening, or the loosening may have caused the malalignment, however, the sequence of events cannot be confirmed.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information 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: LOGIC CR FEMORAL CEM, RIGHT, SZ 4
• 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: 17682369
• Report Number: 1038671-2023-02147
• Device Sequence Number: 12323835
• Product Code: JWH
• UDI-Device Identifier: 10885862158130
• UDI-Public: 10885862158130
• 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: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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 Expiration Date: 05/30/2023
• Device Catalogue Number: 02-010-03-0340
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2013
• 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 H10.
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 69 KG