MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Osteolysis (2377); Joint effusion (4849)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.200-02-38 - three peg patella 38mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 64 yo male patient, initial left knee implanted on november 2015, underwent a revision procedure in (b)(6) 2023, approximately 8 years post the initial procedure.The patient has had increasing effusions and pain for the last 2-3 years.Infection work-up was negative.Preoperative diagnosis indicated a failed bilateral total knee arthroplasty secondary to polyethylene wear, osteolysis.Operative notes indicated there were osteolytic debris and synovial inflammation.A subtotal synovectomy was performed.The patella was everted and found to be oxidated and delaminated.The patella was prepared for a 35mm patella button with a composite thickness if 24mm.The insert was removed.The femoral and tibial components were found well fixed.A 13 insert was implanted.There were no device breakages or surgical delays.The patient was last known to be in stable condition following the event.No device returns anticipated.Due to the recall the hospital will not release them.X-rays and device images were provided.No further information.This is 1 of 2 reports for the left knee.Right knee revision reported under mdr#1038671-2023-02900 and 1038671-2025-01517.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6 the following sections were corrected: d1/d2a/d2b, h6 mdr section codes updated/corrected: b, c, d the reason for the revision reported was likely due to the reported pain, femoral loosening of the right knee, or due to the inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the tibial tray to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the damage to the polyethylene appears unremarkable in the provided images for a device implanted for 7 years.The extent and root cause of the prosthesis wear and femoral loosening could not be determined as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b.Serial number is unknown.The reason for the revision reported was likely due to the reported pain, femoral loosening of the right knee, or due to the inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the tibial tray to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the damage to the polyethylene appears unremarkable in the provided images for a device implanted for 7 years.The extent and root cause of the prosthesis wear and femoral loosening could not be determined as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 11MM
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21568992
• Report Number: 1038671-2025-01529
• Device Sequence Number: 12818571
• Product Code: JWH
• UDI-Device Identifier: 10885862001894
• UDI-Public: 10885862001894
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 03/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-35-4011
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 03/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/13/2025; 03/13/2025
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 111 KG