MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	02-012-44-2515
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint effusion (4849)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department the patient had a left knee replacement on (b)(6) 2016.Approximately 6 years and 6 months after the initial surgery the patient had a left knee revision on (b)(6) 2022 due to profound swelling.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report: (b)(6) 2023/ k mcguinness received via legal 11 apr 2023.Diagnosis: failed left knee secondary to wear of the bearing surface.There was a very large synovial effusion that consisted primarily of monocytes and macrophages.No evidence of loosening of the patient's components on preoperative x-rays.During surgery there was very extensive synovial expansion with foreign body-type reaction.No sign of osteolysis but the tibial polyethylene insert showed severe wearing and delamination.No complications during the procedure.The patient was awakened and taken to the recovery room in stable condition.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
Additional information h3: the revision reported in the case was likely the result of prosthesis wear as stated in the operative notes.The extent and root cause of the prosthesis wear cannot be determined as the device was not returned for evaluation, and radiographs and photographs were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16843531
• Report Number: 1038671-2023-00868
• Device Sequence Number: 15175791
• Product Code: JWH
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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: 12/16/2021
• Device Model Number: 02-012-44-2515
• Device Catalogue Number: 02-012-44-2515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 09/17/2026
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 09/13/2023; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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: A
• 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: 61 YR
• Patient Sex: Female