MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-4009
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 6607062 200-02-35 - three peg patella 35mm.6636172 02-010-04-0340 - logic cr femoral por, right, sz 4.3604441 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.
Event or Problem Description
It was reported that this 53 y/o female patients right knee was revised 1.5 years post op.The patient was revised due to osteolysis, loosening and poly wear.Patient was last known to be in stable condition following the event.No product return; disposed at hospital.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the implants and the bone.Based on the images provided, there does not appear to be excessive wear of the insert.However, this cannot be confirmed because the devices were not returned for evaluation.
Additional Manufacturer Narrative
H6: corrected medical device problem code and component code.
Additional Manufacturer Narrative
The following sections have corrected information: (h60 investigation findings, investigation conclusion.
Additional Manufacturer Narrative
Report number: 1038671-2024-03320 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8 h10 the following sections were corrected: b2 h6 the revision reported may have been the result of loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the implants and the bone.Based on the images provided, there does not appear to be excessive wear of the insert.However, this cannot be confirmed because the devices were not returned for evaluation.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 4, 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: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18499081
• Report Number: 1038671-2024-00083
• Device Sequence Number: 7948615
• Product Code: JWH
• UDI-Device Identifier: 10885862230485
• UDI-Public: 10885862230485
• 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: 2022
• 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,Followup,Followup
• Report Date (Section B): 01/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-51-4009
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 03/01/2024; 03/01/2024; 10/18/2024; 10/18/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/18/2024; 09/19/2024; 11/06/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female