MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 3.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
*additional information received from legal on 21-jul-2023* implantation product (left): ¿ optetrak logic tibial insert (02-012-35-3509, (b)(6)) ¿ optetrak logic femoral component posterior stabilized (02-010-01-0235, (b)(6)) ¿ optetrak logic fit tibial tray (02-012-45-3535, (b)(6)) ¿ optetrak 3 peg patella (200-02-32, (b)(6)) date of surgery: (b)(6) 2014 surgeon: (b)(6) md place: (b)(6) specifics: ¿ bilateral degenerative joint disease ¿ bilateral tka revision product: ¿ zimmer femoral and tibial components date of surgery: (b)(6) 2022 surgeon: (b)(6) md place: (b)(6) specifics: ¿ revision left tkr ¿ extensive poly wear with loosening of hardware ¿ significant amount of polyethylene debris and pale tannish brown tissue loosely floating in knee.Femoral component grossly loose.Significant amount of fibrin in femur.Debris found under medial tibial base plate *original description summary* legal case - lk it was reported via a legal notification that a male patient, initial bilateral knee implanted on (b)(6) 2014, who was implanted with optetrak devices, including optetrak logic tibial inserts, size 3.5, 9 mm made of polyethylene, underwent a left knee revision procedure on (b)(6) 2022, approximately 7 years 11 months post the initial implant procedure upon information and belief, the loose components and osteolysis in plaintiff¿s left knee was due to premature polyethylene wear of the tibial insert.Despite undergoing revision surgery, plaintiff experiences daily pain and discomfort in his left knee which limits his activities of daily living and impacts his quality of life.*note: left or right knee serial number is not indicated in legal document.
Additional Manufacturer Narrative
D10: concomitants: 02-012-35-3509 - logic tibia ps mod insrt sz 3.5 9mm (b)(6), 2820567 02-010-01-0335 - logic femoral ps cem right sz 3.5 2945721 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t (b)(6) 1500-s - cemex system 80g aa7196 200-02-32 - three peg patella 32mm (b)(6) 201-78-89 - 3" drill bit, mod.Hex 2 pack (b)(6) 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19 (b)(6) asa0030 - sterile disposable containers aa7229, aa7857.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 96 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening, ambulation difficulties, discomfort, failure of implant, joint effusion, osteolysis, and pain.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.".

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 3.5
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21080679
• Report Number: 1038671-2025-00087
• Device Sequence Number: 8333799
• Product Code: JWH
• UDI-Device Identifier: 10885862001153
• UDI-Public: 10885862001153
• 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: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 10/15/2018
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 3.5
• Device Catalogue Number: 02-010-01-0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male