MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-35-3513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): (b)(4), 02-012-35-3513 - logic tibia ps mod insrt sz 3.5 13mm; serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(4), 201-78-89 - 3" drill bit, mod.Hex 2 pack; (b)(4), 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t; (b)(4), 200-02-32 - three peg patella 32mm; (b)(4), 201-78-82 - collar fixation pin 2pk 40mm, quick release; (b)(4), 02-010-01-0235 - logic femoral ps cem left sz 3.5.
Event or Problem Description
As reported, approximately 7 years post op the initial left tka, this 99 y/o patient was revised due to pain and wear.Patient had a recalled implant.The medial aspect of the joint space seemed slightly thinner than the lateral aspect indicating wear.The femur debonded from the cement mantle.The poly showed signs of degradation and wear.Patient was last known to be in stable condition following the event.No other patient/medical information provided.Devices are not returning, the hospital does not allow for the return of explants.
Additional Manufacturer Narrative
H3: investigation results: the revision reported was likely the result of prosthesis wear that may have been secondary to gross instability of the knee and other patient-related issues.A contributing factor to the extent of wear on the tibial insert may have been the result of being packaged in a non-conforming bag for five years.Prosthesis wear may have contributed to particle-induced osteolysis.The reported femoral loosening due to loss of mechanical fixation at the cement-implant interface may be the result of the revision procedure as the operative report states that it appeared to be well-fixed at the time of initial testing.
Event or Problem Description
Revision operative report of (b)(6) 2022: failed left knee arthroplasty, revision of femoral component and tibial liner.The patient presented with pain and was found to have eccentric wear of the polyethylene.Findings: large joint effusion, inflamed synovium, polyethylene liner wear with delamination and wear particularly posteromedially, loose debonded femoral component with osteolysis involving the medial femoral condyle.The patient emerged from anesthesia in stable condition.There were no intraoperative complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely the result of prosthesis wear that may have been secondary to gross instability of the knee and other patient-related issues.A contributing factor to the extent of wear on the tibial insert may have been the result of being packaged in a non-conforming bag for five years.Prosthesis wear may have contributed to particle-induced osteolysis.The reported femoral loosening due to loss of mechanical fixation at the cement-implant interface may be the result of the revision procedure as the operative report states that it appeared to be well-fixed at the time of initial testing.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 3.5 13MM
• 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: miguel sosa ; 3523771140
• MDR Report Key: 16095721
• Report Number: 1038671-2023-00014
• Device Sequence Number: 15132764
• Product Code: JWH
• UDI-Device Identifier: 10885862001863
• UDI-Public: 10885862001863
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 07/10/2025

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: 12/30/2018
• Device Model Number: 02-012-35-3513
• Device Catalogue Number: 02-012-35-3513
• Device Lot Number: 04184011
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/18/2023; 07/09/2025
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/02/2024; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown