MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case usa.Original description summary: as reported via legal documentation the patient had a left knee replacement on (b)(6) 2015.Approximately 7 years and 3 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Unable to locate surgeon/patient/serial number in ebi.No serial numbers available.Historical record and smartsolve searched for sn/patient name with no results.Additional information: implant date: (b)(6) 2015, dr.(b)(6).Explant date: (b)(6) 2022, dr.(b)(6).As reported via legal documentation the patient had a left knee replacement on (b)(6) 2015 due to osteoarthritis.Approximately 7 years and 3 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.Revision op report postoperative diagnosis: aseptic loosening, left total knee.There was extensive friable synovitis consistent with loosening and an aggressive synovectomy was performed.The surgeon noted the femur was wiggling clinically and was able to be removed by hand.Underneath the cement was fairly extensive cavitary defects and the majority of the lateral femoral condyle was hollowed out and a large area of femoral metaphysis was hollowed out.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.No device return anticipated due to this being a legal case.
Additional Manufacturer Narrative
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 device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10: concomitants: (b)(6), 02-010-03-0240 - logic cr femoral cem, left, sz 4.(b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 02-012-49-4011 - logic cr tib insert slope++, sz 4, 11mm.(b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2015.Approximately 7 years and 3 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20879794
• Report Number: 1038671-2024-04709
• Device Sequence Number: 8955645
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 04/30/2023
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• Device Catalogue Number: 02-012-49-4011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 04/30/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male