MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 4 15MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Insufficient Information (4580); Medical device site infection (4845)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-010-01-0240 - logic femoral ps cem left sz 4 - 3870561.201-78-82 - collar fixation pin 2pk 40mm, quick release - 3874746.200-02-35 - three peg patella 35mm - 3882599.02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t - 3894761.No device return anticipated.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal filing that a male patient, who was initially implanted on (b)(6) 2015 on his left knee with an optetrak tka system, indicated the tka system had failed in (b)(6) 2016 and underwent revision surgery approximately 1 year 3 months post the initial implant procedure.They removed the implant and replaced it with another joint replacement system.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
Revision operative notes were provided.Indications: 1.Infected left total knee arthroplasty.2.Retained hardware (screw left femoral distal shaft).Preoperative and postoperative diagnosis: n/a.Operation: 1.Resection of left total knee arthroplasty, with placement of antibiotic-impregnated spacer.2.Removal of hardware, deep, left distal femur.Description of operation: there was gross purulence in the knee and significant synovitis.Multiple cultures were sent.The polyethylene was dissociated and the components were removed in the usual fashion without any significant associated bone loss.Cement was removed with a high-speed bur.The previous screw was located and removed.Additional ethibond along the track of an old acl reconstruction was also carefully removed with a bur.I also removed the old acl graft remnants from the anterior tibia.Checked everything fluoroscopically; it looked clean.Irrigated it thoroughly with saline clorpactin and plain saline.The patient was revised to a competitor¿s antibiotic spacer.The patient was transferred to the recovery room without complication.
Additional Manufacturer Narrative
Additional information: b5.Corrected information: h6: health effect-clinical code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, infection 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 PS MOD INSRT SZ 4 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 32653 ; 3523771140
• MDR Report Key: 15179686
• Report Number: 1038671-2022-00894
• Device Sequence Number: 12317705
• Product Code: JWH
• UDI-Device Identifier: 10885862001917
• UDI-Public: 10885862001917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 06/08/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 15MM
• Device Catalogue Number: 02-012-35-4015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 09/26/2024; 06/30/2025
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 01/11/2023; 10/14/2024; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2010
• 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: Male