MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Discomfort (2330); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-45-1505 - lgc tibial fit tray cem sz 1.5f / 0.5t.(b)(6) 02-010-03-0315 - logic cr femoral cem, right, sz 1.5.(b)(6) 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(6) 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6) 02-012-48-1509 - logic cr tib insert slope +, sz 1.5, 9 mm.(b)(6) 02-010-03-0215 - logic cr femoral cem, left sz 1.5.(b)(6) 521-78-23 - threaded pin size 2.3 collared 2pk.(b)(6) 200-02-29 - three peg patella 29mm.(b)(6) 200-02-29 - three peg patella 29mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a bilateral on (b)(6) 2016.Following the surgeries, the patient began experiencing severe pain, swelling, and unsteadiness in both knees, and significant gait impairment.The patient continued to have pain, swelling, and discomfort in her right knee.X-rays were ¿suggestive of possible wear of polyethylene of the knee.¿ on (b)(6) 2022 the patient underwent a right knee revision surgery.The surgeon¿s operative findings included ¿some arthrofibrosis of [patient's] right total knee arthroplasty¿ and ¿wear noted on the polyethylene of the right total knee arthroplasty.¿.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6 the following sections were corrected: h6 mdr section codes updated/corrected: a, b, c, d, g.

• Brand Name: LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17425035
• Report Number: 1038671-2023-01815
• Device Sequence Number: 5931177
• Product Code: JWH
• UDI-Device Identifier: 10885862144379
• UDI-Public: 10885862144379
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 08/01/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• Device Catalogue Number: 02-012-48-1509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown