MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-49-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 2631676 02-010-03-0220 - logic cr femoral cem, left sz 2; 2556773 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; 1806929 200-05-23 - inset patella 23mm.Recall: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2013.The patient was revised on (b)(6) 2022.The surgeon opened the knee joint, performed a synovectomy, and removed any scar tissue.The surgeon then examined the implants, noting that the patella had substantial wear.An osteotome and removal tool were used to remove the poly.The implant showed to be broken and in pieces posteriorly.It showed delamination and pitting.The poly remnants were removed and the knee was irrigated well.The metal implants were well fixed.
Additional Manufacturer Narrative
H3: the reason for the pain and stiffness leading to the revision reported cannot be confirmed from the provided information but may have been the result of patient conditions, prosthesis wear of the patellar component over 9.5 years of implantation, or edge wear of the tibial insert secondary to bony overhang on the femoral side.A contributing factor to the revision may have been inclusion of the implanted polyethylene tibial insert in the packaging recall.However, the articular surface of the returned tibial insert appears unremarkable for prosthesis wear.B4 is updated with new information received.
Event or Problem Description
There is part of the poly missing on the side.There was inflammation within the tissues of the joint, the poly was removed and the knee joint was irrigated.There was not many pieces in the joint and the poly was not chewed or deformed posteriorly.Very little pieces of the poly were removed visually and through the irrigation process.
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, e, g.The reason for the pain and stiffness leading to the revision reported in cannot be confirmed from the provided information but may have been the result of patient conditions, prosthesis wear of the patellar component over 9.5 years of implantation, or edge wear of the tibial insert secondary to bony overhang on the femoral side.A contributing factor to the revision may have been inclusion of the implanted polyethylene tibial insert in the packaging recall.However, the articular surface of the returned tibial insert appears unremarkable for prosthesis wear.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 2, 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15675547
• Report Number: 1038671-2022-01355
• Device Sequence Number: 20426079
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• 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: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2025

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 Expiration Date: 09/18/2020
• Device Model Number: 02-012-49-2009
• Device Catalogue Number: 02-012-49-2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 06/06/2025
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 03/07/2023; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 92 KG