MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0220
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-02318.Concomitant devices: tibial tray trpzd logic (cat no.Unknown, sn (b)(6), 3 peg patella (cat no.Unknown, sn (b)(6), tibial insert (cat no.Unknown, sn (b)(6), optetrak logic spacer tib (cat no.Unknown, sn (b)(6), stryker simplex hv w/ gent bone cement x 2.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2016.Approximately 6 years and 10 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.The patient experienced pain, stiffness, discomfort, and weakness.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
1038671-2024-03518; 1038671-2023-02318 the revision reported was likely the result of prosthesis wear of the tibial insert and patella component, in addition to loosening of the femoral component and patella component, as stated in the revision operative notes.The aseptic (non-infected) loosening was likely due to an insufficient bond between the implants and the bones.However, the reported prosthesis wear and loosening could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images or radiographs were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 82 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening, ambulation or postural difficulties, osteolysis, synovitis, joint laxity and pain.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Event or Problem Description
It was reported via legal documentation that approximately 82 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, loosening, ambulation or postural difficulties, osteolysis, synovitis, joint laxity 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 20218026
• Report Number: 1038671-2024-03517
• Device Sequence Number: 7745765
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 02-010-01-0220
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/12/2024; 09/12/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 09/16/2024; 03/12/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 68 YR
• Patient Sex: Unknown