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	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years post op initial right tka, this male patient was revised due to poly wear and femoral loosening.The tibial insert and femoral component were revised with new components.There was no change in size.Patient was last known to be in stable condition following the event.Unable to obtain x-rays.Product not returning: disposed.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 6095402 02-010-04-0350 - logic cr femoral por, right, sz 5.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of femoral loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and the bone.The tibial insert wear may have been due to possible bony overhang, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
*the following sections have corrected information: (h6) health effect - clinical code, type of investigation, investigation findings, investigation conclusion.
Additional Manufacturer Narrative
Report number: 1038671-2024-03013 this follow-up report is being submitted to relay additional and/or corrected information.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 following sections were updated: h10.The following sections were corrected: b2.D4: serial number and expiration date d8.D10 concomitants: (b)(6) 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-32 - threaded pin size 3.0 collarless.The revision reported may have been the result of femoral loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and the bone.The tibial insert wear may have been due to possible bony overhang, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of femoral loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and the bone.The tibial insert wear may have been due to possible bony overhang, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18187329
• Report Number: 1038671-2023-02835
• Device Sequence Number: 7321683
• 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: 2020
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2025
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/07/2024; 10/18/2024; 10/18/2024; 10/18/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/20/2024; 11/06/2024; 01/09/2025; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Male