MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: three peg patella 29mm - 200-02-29 - 5670403.Logic cr femoral por, left, sz 5 - 02-010-04-0250 - 6265790.Lgc tibial fit tray cem sz.5f / 5t - 02-012-45-5050 - 6705617.
Event or Problem Description
As reported, the patient had an previous revision on (b)(6) 2023.The patient was revised again on (b)(6) 2023 due to patella wear and poly wear; there was no change in sizing.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of third body wear, orientation of the components, patient related condition, instability, or any combination of these possibilities, which led to wear and/or deformation of the tibial insert and patella.However, this cannot be confirmed because the components were not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of prosthesis wear and femoral loosening.The wear and/or deformation of the tibial insert and patella may have been the result of third body wear, orientation of the components, patient related conditions, instability, or any combination of these possibilities.The loosening may have been the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the components were not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
Report number: 1038671-2024-03169, 1038671-2024-04027 this follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of prosthesis wear and femoral loosening.The wear and/or deformation of the tibial insert and patella may have been the result of third body wear, orientation of the components, patient related conditions, instability, or any combination of these possibilities.The loosening may have been the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the components were not returned for evaluation and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18290922
• Report Number: 1038671-2023-02948
• Device Sequence Number: 12429114
• Product Code: JWH
• UDI-Device Identifier: 10885862230560
• UDI-Public: 10885862230560
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/09/2025

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 Catalogue Number: 02-012-51-5009
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 02/21/2024; 10/16/2024; 10/16/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/05/2024; 10/18/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 107 KG