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

Catalog Number	02-010-03-0235
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product 200-02-35 three peg patella 35mm reported under 038671-2024-02459.Product 02-012-47-3509 logic cr tib insert std, sz 3.5, 9 mm reported under 1038671-2024-00871.D10: concomitants: 4576988 - 02-012-47-3509 - logic cr tib insert std, sz 3.5, 9 mm.5245724 - 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.5310308 - 200-02-35 - three peg patella 35mm.5248761 - 201-78-15 - holding pin mini sharp point 4 pk.5340556 - 521-78-23 - threaded pin size 2.3 collared.5340576 - 521-78-23 - threaded pin size 2.3 collared.5260743 - 521-78-32 - threaded pin size 3.0 collarless.1000018027 - a10012 - gps implant kit v2.H3: the revision reported was likely the result of presumed prosthesis wear, instability, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation.
Event or Problem Description
It was reported that a female patient, initial left knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2024, approximately 5 years 11 months post the initial procedure.The patient was revised due to femur loosening from poly and patella wear.Everything was removed.There were no device breakages or surgical delays during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis as they were disposed of by the hospital.Device images were provided.No further information.

• Brand Name: OPTETRAK 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19787187
• Report Number: 1038671-2024-02460
• Device Sequence Number: 18249933
• Product Code: JWH
• UDI-Device Identifier: 10885862158024
• UDI-Public: 10885862158024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2026
• Device Catalogue Number: 02-010-03-0235
• 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: 03/28/2024
• Initial Report FDA Received Date: 07/20/2024
• Date Device Manufactured: 09/13/2016
• 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: Required Intervention
• Patient Sex: Female