MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification, that patient's second optetrak logic psc tibial insert implanted in plaintiff on (b)(6) 2018 failed, causing plaintiff knee pain and difficulty walking.Due to the pain, discomfort, and difficulty walking related to the second optetrak logic psc tibial insert implanted into plaintiff, plaintiff was forced to undergo a second revision surgery on (b)(6) 2019, approximately 1 year 5 months post revision procedure, at which time she was implanted with a third tibial insert.Again, tellingly, during the second revision procedure, plaintiff¿s surgeon noted there was ¿loosening of the tibial component¿ that required the second revision surgery.The insert implanted into plaintiff¿s knee on (b)(6) 2019 is an exactech truliant psc tibial insert¿an insert that has since been recalled.At this time, it is unknown whether the truliant psc tibial insert implanted into plaintiff has failed like the previous two optetrak logic psc tibial inserts implanted into plaintiff, but plaintiff continues to suffer pain, discomfort, and difficulty walking, all relating to the multiple revision surgeries she has undergone due to the failures of the two optetrak logic psc tibial inserts implanted into her right knee.To this day, plaintiff continues to experience pain, discomfort, difficulty walking, and limited range of motion as a result of the initial implant of the device as well as the subsequent revision surgeries.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 4882023, 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t; 4886792, 02-012-50-2011 - logic fit/rbk augment 1/2 block sz 2, 5mm; 4886805, 02-012-50-2011 - logic fit/rbk augment 1/2 block sz 2, 5mm; 5180835, 02-012-60-1440 - logic stem ext 14mm x 40mm; 5367594, 204-70-00 - tibial stem ext.Screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and tibial loosening 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: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
• 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: 16485668
• Report Number: 1038671-2023-00349
• Device Sequence Number: 5659812
• Product Code: JWH
• UDI-Device Identifier: 10885862173577
• UDI-Public: 10885862173577
• 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: 2018
• Device Explanted Year: 2019
• 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: 03/09/2023
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
• Device Catalogue Number: 02-012-44-3013
• 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
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• 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: 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 Sex: Unknown