MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2015
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Joint effusion (4849)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that this female patient's right knee was revised due to evolving chronic laxity, functional impairment instability, femoral metaphyseal pain, chronic hydrartrosis , and wear of pe insert with femoral geode cavity femoral loosening.Patient was last known to be in stable condition following the event.No other patient information/medical information provided.Unable to obtain photos/x-rays.Devices are returning.
Additional Manufacturer Narrative
Section h10: (d4) expiration date: 18-apr-2023.(h3) the revision reported was likely the result of gross instability, patient-related conditions, malalignment between the femoral and tibial components, an insufficient bond between the femoral component and bone, or any combination of these possibilities, which polyethylene wear of the tibial insert and aseptic (non-infected) femoral loosening.(h4) device manufacture date: 20-apr-2015.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings; 7455, part/component/sub-assembly term not applicable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of gross instability, patient-related conditions, malalignment between the femoral and tibial components, an insufficient bond between the femoral component and bone, or any combination of these possibilities, which polyethylene wear of the tibial insert and aseptic (noninfected) femoral loosening.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 2 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16988216
• Report Number: 1038671-2023-01093
• Device Sequence Number: 17875446
• Product Code: JWH
• UDI-Device Identifier: 10885862001757
• UDI-Public: 10885862001757
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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: 04/18/2023
• Device Catalogue Number: 02-012-35-2015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 02/07/2025
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/24/2023; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female