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

Model Number	LOGIC CC FEMORAL SIZE 4, LEFT
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4694401 02-010-06-0541 - logic post.Aug.Block size 4, 5mm, 2916041 02-012-35-4017 - logic ps tib ins sz 4 17mm, 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.(b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported 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 surgeon revised the femoral components for a logic cc knee.The femoral components were loose.The tibial components were well fixed.The patient was last known to be in stable condition following the event.The product is not returning, no reason provided.No additional information provided.
Additional Manufacturer Narrative
H6: the revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening, pain, and instability.However, this cannot be confirmed as the devices were not available for evaluation and images of the explanted devices/pre-revision radiographs were not provided.
Event or Problem Description
This patient was part of the exactech cc clinical study.The patient presented 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 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.
Event or Problem Description
The patient has filed a short-form complaint in a coordinated action in (b)(6) with master case no.(b)(4).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action 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.
Additional Manufacturer Narrative
Additional information b5, g4 corrected information h6-health effect clinical code, medical device problem code.
Additional Manufacturer Narrative
1038671-2024-04134.1038671-2024-04133.A4: corrected the following: patient weight.B1: corrected the following: type of report (check all that apply).B2: corrected the following: outcomes attributed to adverse event (check all that apply).G1: corrected the following: reporting contact name prefix/title (dr., mrs., etc.), reporting contact first name, reporting contact last name.H6: corrected the following: component code, type of investigation, 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: 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: geoff gannon ; 3523771140
• MDR Report Key: 15877848
• Report Number: 1038671-2022-01521
• Device Sequence Number: 11385854
• Product Code: JWH
• UDI-Device Identifier: 10885862265678
• UDI-Public: 10885862265678
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,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: 03/01/2022
• Device Model Number: LOGIC CC FEMORAL SIZE 4, LEFT
• Device Catalogue Number: 02-010-06-0240
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 06/19/2023; 10/23/2024; 11/18/2024
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 06/19/2023; 10/27/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 143 KG