MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 3, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post initial right tka, this (b)(6) male patient had a total knee replacement which failed.Patient reason for the revision was poly failure.There is lots of poly wear and it had a sandpaper texture to it.It was discolored and yellow in spots.There was osteolysis.Surgeon saw the patient in clinic and recognized a failing component.Patient revised to competitor's device.There was no parts or pieces fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device will be return.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, right, sz 3 (cat# 02-010-03-0330 / serial# (b)(4)).Lgc tibial fit tray cem sz 3f / 4t (cat# 02-012-45-3040 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of incomplete seating of the tibial insert at the time of implantation.Incomplete seating likely caused anterior migration of the tibial insert and axial rotational mismatch of the femoral component relative to the tibial components, which resulted in excessive posterior contact, especially medially, and led to severe wear of the polyethylene and the medial edge of the tibial tray.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported in was likely the result of incomplete seating of the tibial insert at the time of implantation.Incomplete seating likely caused anterior migration of the tibial insert and axial rotational mismatch of the femoral component relative to the tibial components, which resulted in excessive posterior contact, especially medially, and led to severe wear of the polyethylene and the medial edge of the tibial tray.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 3, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14161293
• Report Number: 1038671-2022-00437
• Device Sequence Number: 11512296
• Product Code: JWH
• UDI-Device Identifier: 10885862174437
• UDI-Public: 10885862174437
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 06/26/2025

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: 06/17/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 3, 13MM
• Device Catalogue Number: 02-012-49-3013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 11/17/2022; Not provided
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 12/05/2022; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male