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

Catalog Number	02-012-35-4017
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via an experience report, a cc clinical study, and through legal notification, that a 64 yo male patient, initial left knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2022, approximately 4 years 7 months post the initial procedure.The patient presented to the clinic on (b)(6) 2018, with a patellar sleeve fracture that presents as clicking laterally with flexion but is not painful.Indication for revision surgery stated aseptic loosening, instability, and pain/stiffness.Date of onset was unknown.The surgeon revised the femoral components for a logic cc knee.The femoral components were loose.The tibial components were well fixed.The study indicates the event is possibly related to the devices and the procedure.The femoral, patella, tibial insert and tray components were revised.The study indicates the event was resolved on the surgery date.No device returned due to clinical study guidelines.The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits were required ¿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.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.No additional information provided.
Additional Manufacturer Narrative
D10 concomitants: 4694401 -02-010-06-0541 - logic post.Aug.Block size 4, 5mm 2046914 -02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t 4562441 -02-012-60-1480 - logic stem ext 14mm x 80mm 4539233 -02-012-60-2080 - logic stem ext 20mm x 80mm 4690545- 02-012-61-4000 - logic offset stem ext coupler 4mm 5014271- 02-012-61-4000 - logic offset stem ext coupler 4mm 4996346- 204-70-00 - tibial stem ext.Screw 3984131- 208-05-04 - cc distal fem augment sz 4, 5mm 4536864 -208-06-04 - cc distal fem augment sz 4, 10mm.
Additional Manufacturer Narrative
1038671-2022-01521.1038671-2024-04133 b2: corrected the following: b2 outcomes attributed to adverse event (check all that apply) h6: corrected the following: type of investigation, investigation findings, investigation conclusions the reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, bone fracture, and prosthesis wear 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, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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: 20541500
• Report Number: 1038671-2024-04134
• Device Sequence Number: 8324943
• Product Code: JWH
• UDI-Device Identifier: 10885862247414
• UDI-Public: 10885862247414
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• 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: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 01/08/2022
• Device Catalogue Number: 02-012-35-4017
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/27/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 143 KG