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

Model Number	02-012-48-3013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 5502023, 02-010-03-0330 - logic cr femoral cem, right, sz 3.5460129, 02-012-45-3040 - lgc tibial fit tray cem sz 3f / 4t.5495458, 200-02-35 - three peg patella 35mm.Correction/removal number: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2018.The patient presented back to the surgeon with complaints of pain, swelling, and dissatisfaction with their right tka.After examination, the patient was scheduled for initial revision surgery on (b)(6) 2022, where all of the exactech implants were removed from the patient.The poly showed wear and is a part of the recall.An infection prophylactic antibiotic tka was placed on (b)(6) 2022.The patient returned on (b)(6) 2022 for the removal of the antibiotic prophylactic tka and was re-implanted with a competitors revision total knee prosthesis.There was no reported breakage of devices and a 45 minute surgical delay.No adverse events as a result of the surgical delay/prolongation.The patient required prolonged hospitalization as a direct result of this issue.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of prosthesis wear and patient-related conditions, which led to pain, swelling, and dissatisfaction of the right knee.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the devices were not returned for evaluation.
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 prosthesis wear and patient-related conditions, which led to pain, swelling, and dissatisfaction of the right knee.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as 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 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16492620
• Report Number: 1038671-2023-00375
• Device Sequence Number: 15026937
• Product Code: JWH
• UDI-Device Identifier: 10885862174406
• UDI-Public: 10885862174406
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 06/29/2024
• Device Model Number: 02-012-48-3013
• Device Catalogue Number: 02-012-48-3013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 01/07/2025
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 07/27/2023; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 122 KG