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

Catalog Number	02-010-01-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Abdominal Pain (1685); Osteolysis (2377); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related: mfr #1038671-2024-01943 report 1 of 2.Additional manufacturer narrative- report 2 of 2.D10.Concomitants: 1619428 02-012-39-5060 - logic tibia fin tray cem sz 5f/6t.1682897 201-78-11 - holding pin small headed short 4 pack.1843705 201-46-10 - holding pin headless 3" (4 pk).1863044 200-02-32 - three peg patella 32mm.1728582 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
It was reported via legal documentation that the patient was implanted with an optetrak logic device on the left knee and then approximately 12 years, 8 months later the patient was revised.It is stated about the patient that they had ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ there was no other patient/medical information provided.No x-rays or images were provided.There is no device return.There is no other information available.
Additional Manufacturer Narrative
1038671-2024-01943.Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-01943.

• Brand Name: LOGIC
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19577203
• Report Number: 1038671-2024-02049
• Device Sequence Number: 8470572
• Product Code: JWH
• UDI-Device Identifier: 10885862001177
• UDI-Public: 10885862001177
• 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: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 09/25/2014
• Device Catalogue Number: 02-010-01-0250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown