MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a male patient, initial right knee implanted with an optetrak device on (b)(6) 2017, underwent a revision procedure on (b)(6)2022, approximately 5 years 1 month post the initial procedure.The plaintiff has suffered and continues to suffer permanent, and debilitating injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed, which all require ongoing medical care.As a further direct, proximate and legal consequence of the defective nature of the optetrak device, plaintiff has sustained and will sustain future damages, including but not limited to cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress; loss of consortium and pain and suffering.No device return anticipated do to this being a legal case.No further information.
Additional Manufacturer Narrative
Concomitant medical products: (b)(4), 02-010-03-0340 - logic cr femoral cem, right, sz 4.(b)(4), 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t.(b)(4), 200-02-35 - three peg patella 35mm.(b)(4), 201-78-15 - holding pin mini sharp point 4 pk.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3.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; however, it is most likely related to the report of pain.There is no other patient medical history available.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
The patient was required to undergo revision surgery due to severe pain, swelling, and instability in the knee and leg.These injuries were caused by early and preventable wear of the polyethylene insert and resulting component loosening and/or other failures causing serious complications including tissue damage, osteolysis, permanent bone loss and other injuries.No other information available.

• Brand Name: LOGIC
• 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 ; 3523771140
• MDR Report Key: 16273829
• Report Number: 1038671-2023-00082
• Device Sequence Number: 5925299
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 05/01/2024

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: 03/04/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• Device Catalogue Number: 02-012-48-4009
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 05/01/2024
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/28/2023; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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