MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3F / 2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 3738541, 02-010-01-0330 - logic femoral ps cem right sz 3; 2999815, 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t; 3798297, 200-02-32 - three peg patella 32mm; 2761904, 201-78-80 - 3" trocar, hex 2pk; 2908271, 201-78-80 - 3" trocar, hex 2pk.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported via legal notification, that patient, was initially implanted on (b)(6) 2015 with the device which failed prematurely, causing pain and difficulty walking, among other injuries and ailments.As a result of the failure of the device, plaintiff was forced to undergo revision surgery on (b)(6) 2018, approximately 3 years 2 months post initial procedure, where plaintiff¿s doctor explanted the device and implanted another optetrak logic psc tibial insert with revision of the right tibial component.Tellingly, during the first revision procedure, plaintiff¿s explanting surgeon noted that plaintiff¿s ¿bone had collapsed medially at the proximal tibia and there was obvious loosening [of the device].¿ due to the complications caused by the first polyethylene optetrak logic psc tibial insert within an optetrak logic tka system, plaintiff spent time in the hospital for treatment and recovery from the revision surgery.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6 the following sections were corrected: d1/d2a/d2b, d4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3F / 2T
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16485569
• Report Number: 1038671-2023-00348
• Device Sequence Number: 17853505
• Product Code: JWH
• UDI-Device Identifier: 10885862003959
• UDI-Public: 10885862003959
• 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: 2015
• Device Explanted Year: 2018
• 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): 01/21/2025

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: 03/17/2024
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
• Device Catalogue Number: 02-012-45-3020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 01/21/2025
• Date Device Manufactured: 03/19/2014
• 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