MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.D10.Concomitant : (b)(4) - 02-010-01-0230 - logic femoral ps cem left sz 3; (b)(4) - 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t; (b)(4) - a10012 - gps implant kit v2 these devices are used for treatments, not diagnosis.There is no other information available.
Event or Problem Description
It is reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2017, with no revision surgery reported.No radiographic images of the device are provided.There is no other information available.
Additional Manufacturer Narrative
H11.Updated/additional information ¿ g1.G2.G4.H6.The revision reported may have been the result of polyethylene wear, instability, and osteolysis as stated in the legal documentation.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the explanted devices were not returned for evaluation and radiographs or photographs were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19086029
• Report Number: 1038671-2024-00801
• Device Sequence Number: 15366585
• Product Code: JWH
• UDI-Device Identifier: 10885862173560
• UDI-Public: 10885862173560
• 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
• 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): 06/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2024
• Device Catalogue Number: 02-012-44-3011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown