MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint effusion (4849)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
Preoperative and postoperative diagnoses indicated failed left total knee arthroplasty secondary to aseptic femoral loosening.Indications for procedure: the patient is a 67-year-old female, who is approximately 10 years status post a left total knee arthroplasty for osteoarthritis.Over the past several months, she has had increasing pain and persistent effusions.X-rays show osteolysis behind the femur and eccentric polyethylene wear.Infection workup has been negative.Description of procedure: upon the knee joint, there was noted to be a large amount of synovial fluid, which was sent for gram stain and culture.The medial and lateral gutters were reestablished.A synovectomy was performed.The patella was everted and found to be well fixed.The knee was flexed.After the patella was subluxed, the previous polyethylene was removed.There was significant wear medially.Femoral component was disimpacted that was loose, tibial component was intact.The patient was revised to exactech devices.The patient was awakened and taken to recovery room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 2 15MM
• 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 ; 3523771140
• MDR Report Key: 20072431
• Report Number: 1038671-2024-03092
• Device Sequence Number: 3048025
• Product Code: JWH
• UDI-Device Identifier: 10885862001757
• UDI-Public: 10885862001757
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 05/17/2018
• Device Catalogue Number: 02-012-35-2015
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2010
• 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: 1753187, 02-012-41-2020 - LOGIC TIBIA TRAPTRAY CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female