MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 15MM
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic femoral ps cem left sz 5 (cat# 02-010-01-0250 / serial# (b)(4)) logic tibia traptray cem sz 5f/5t (cat# 02-012-41-5050 / serial# (b)(4) ) three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, it was reported that patient experienced a right knee dissociated tibial polyethylene liner.The patient squatted down and this preceded the insert dislocating.The knee was revised.Devices are not returning.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of the tibial insert disassociating from the tibial tray, possibly due to patient-related conditions, a post traumatic event, incomplete seating of the tibial insert at the time of implantation, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "disassembled / misassembled" is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of polyethylene dissociation, osteolysis, and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.The tibial insert dissociation from the tibial tray could be due to patient-related conditions, a post traumatic event, incomplete seating of the tibial insert at the time of implantation, or any combination of these possibilities.The extent and root cause of the polyethylene dissociation, osteolysis, and femoral loosening could not be determined as the devices were not returned for evaluation, and images were not provided.
Additional Manufacturer Narrative
Further information and/or re-opened investigation findings will be provided within 30 days of their receipt.
Event or Problem Description
As reported via legal documentation, this patient had left knee replacement surgery on (b)(6) 2014.They underwent left knee revision surgery on (b)(6) 2020, approximately 6 years 6 months after their primary surgery.(b)(6) 2020 op report postoperative diagnosis: failed left total knee arthroplasty secondary to aseptic loosening; polyethylene disassociation.The surgeon noted the polyethylene had disassociated from the tibial baseplate and removed manually.The femoral component was loosely affixed and removed, leaving residual cement and large cavitary defects in the metaphysis of the distal femur.The tibial component was solidly affixed and removed, extracting all cement.The patient was awakened and transferred to the recovery room.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.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 15MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32553 ; 3523771140
• MDR Report Key: 11683319
• Report Number: 1038671-2021-00175
• Device Sequence Number: 4157720
• Product Code: JWH
• UDI-Device Identifier: 10885862173744
• UDI-Public: 10885862173744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 15MM
• Device Catalogue Number: 02-012-44-5015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 05/05/2023; 12/04/2023
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 06/27/2021; 07/06/2023; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male