MAUDE Adverse Event Report: EXACTECH, INC. LOGIC INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-012-44-4009
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6), 2017.They had an arthroscopy and partial synovectomy on (b)(6), 2022.On (b)(6), 2023 they underwent right knee revision surgery, approximately 6 years 1 month after their primary implantation.On (b)(6), 2022 op report: a chlysis of the patellofemoral joint was performed to free up from the patellar entrapment.Scar tissue was removed suprapatellar, medial and lateral gutters and peripatellar.The patient had minimal debris synovitis, which was debrided.On (b)(6), 2023 op report postoperative diagnosis: infection and inflammatory reaction due to internal orthopedic device.Clear fluid was encountered; there was no purulence.Surgeon noted significant scar tissue in both the medial and lateral gutters.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.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H10.Additional/updated information- b3, b7, d1, d4 catalog #, sn, expiry date, udi, d6b, g4 510k, h4, h6 health effect - clinical code, medical device problem code, h7, h9.H6.Investigation results-the tibial insert with sn (b)(6) was confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s condition/infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Event or Problem Description
Explant date: total right knee revision to competitor's devices on (b)(6) 2023.

• Brand Name: LOGIC INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: michael crader ; 3523782617
• MDR Report Key: 17357575
• Report Number: 1038671-2023-01707
• Device Sequence Number: 12393080
• Product Code: JWH
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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
• Device Expiration Date: 03/10/2024
• Device Catalogue Number: 02-012-44-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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
• 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: 69 YR
• Patient Sex: Male