MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-01345 report number d10: 02-010-01-0230 - logic femoral ps cem left sz 3 02-012-41-3020 - logic tibia traptray cem sz 3f/2t 200-02-35 - three peg patella 35mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01345 the product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The revision reported was likely the result of prosthesis wear, loosening, and osteolysis.The prosthesis wear was likely the result of being implanted for 12 years, as the wear observed in the image provided appears minimal.The aseptic (non-infected) femoral loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.However, the root cause and extent of the reported prosthesis wear, femoral loosening, and osteolysis could not be determined as the devices were not returned for evaluation, and images/radiographs were not provided.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
*additional information received from legal on 31jul2023* as reported via legal documentation, a patient had left knee replacement surgery on 15 nov 2010.The patient began experiencing increasing pain, ¿shifting of her knees,¿ and impaired mobility.Recurrent effusions and increasing pain also began occurring.X-rays demonstrated evidence of femoral osteolysis.The surgeon diagnosed the patient with failed left total knee arthroplasty secondary to polyethylene wear, osteolysis, and femoral loosening, and revision surgery was recommended.Patient underwent a left knee revision surgery, approximately 12 years 6 months post primary procedure.During the revision surgery, the orthopedic surgeon found polyethylene debris in the synovial tissue and osteolysis of the left tibia.¿significant uncontained osteolysis in the posterior medial and posterolateral condyles¿ of the femur was also noted.There is no other patient demographic or medical history available.There is no device return.No additional information is available.*original description summary* as reported, approximately 12.6 years post initial left tka, the patient complaint of pain.Patient had a revision due to loose femur and recalled poly.Patient was revised to exactech devices.There was no breakage of device and surgical delay/prolongation.Patient was last known to be in stable condition following the event.Image and x-ray received.The device is not available for evaluation due to recall devices hospital will not release.**the revision reported was likely the result of prosthesis wear, loosening, and osteolysis.The prosthesis wear was likely the result of being implanted for 12 years, as the wear observed in the image provided appears minimal.The aseptic (non-infected) femoral loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.However, the root cause and extent of the reported prosthesis wear, femoral loosening, and osteolysis could not be determined as the devices were not returned for evaluation, and images/radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: b.The revision reported was likely the result of prosthesis wear, loosening, and osteolysis.The prosthesis wear was likely the result of being implanted for 12 years, as the wear observed in the image provided appears minimal.The aseptic (non-infected) femoral loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.However, the root cause and extent of the reported prosthesis wear, femoral loosening, and osteolysis could not be determined as the devices were not returned for evaluation, and images/radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 11MM
• 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 66t ct; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66t ct; gainesville, FL 32653
• MDR Report Key: 21240855
• Report Number: 1038671-2025-00426
• Device Sequence Number: 19727916
• Product Code: JWH
• UDI-Device Identifier: 10885862001818
• UDI-Public: 10885862001818
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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
• Report Date (Section B): 02/03/2025

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: 02/10/2018
• Device Catalogue Number: 02-012-35-3011
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2010
• 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: 72 YR
• Patient Sex: Female