MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case-usa: patient id: (b)(6) rk rev.Additional information received from legal on 13-dec-2023: revision operative report of (b)(6) 2023 - postoperative diagnosis- failed right total knee arthroplasty secondary to aseptic femoral loosening, osteolysis; morbid obesity bmi 41.Patient was revised to competitor¿s devices.Marked synovitis.Evidence of polyethylene wear on the undersurface of the patella.No gross evidence of polyethylene wear of the actual insert.Sterile dressings were applied, and the patient was awakened and transferred to the recovery room.There is no other patient/medical information provided.There are no x-rays or images provided.Devices were not returned.There is no other information available.Unable to locate ebi.Revision product: depuy attune knee system components; stryker simplex bone cement.Additional information received from legal on 27-oct-2023: this morning, i talked to (b)(6) about (b)(6)'s claim.Below is a summary of that call: (b)(6) underwent knee replacement for both knee in approximately (b)(6) 2013: he revised his right knee on (b)(6) 2023 right knee.(b)(6) claims his recovery period was tough and he was in severe pain before the revision.Original description summary: this patient is verified bilateral knees on (b)(6) 2013 with dr.(b)(6).He had right knee revision on (b)(6) 2023 with dr.(b)(6).No device return anticipated due to this being a legal case.Ebi initial surgery unable to be found.Historical record & smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.No further information.As directed by qa management: this legal complaint case is from the united states.The event did not occur in, nor is it reportable for brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: 200-02-35, sn (b)(6); 02-012-40-4040, sn (b)(6).
Event or Problem Description
It was reported that approximately 124 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, osteolysis, pain, and synovitis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5.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 IMPLANT PSC INSERT, SZ 4, 15MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21217243
• Report Number: 1038671-2025-00350
• Device Sequence Number: 3517413
• Product Code: JWH
• UDI-Device Identifier: 10885862173669
• UDI-Public: 10885862173669
• 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: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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 Expiration Date: 05/17/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
• Device Catalogue Number: 02-012-44-4015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male