MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-41-5050
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6) 02-010-01-0250 - logic femoral ps cem left sz 5 (b)(6) 02-012-41-5050 - logic tibia traptray cem sz 5f/5t (b)(6) 200-02-35 - three peg patella 35mm.Multiple mdr reports were filed for this event, please see associated reports: case-(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported via legal documentation that approximately 125 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, osteolysis, synovitis, loosening of femoral and tibial tray, intraoperative fracture of femur.His left knee had become extremely painful, and he has gone on to have massive osteolysis in the distal femur and proximal tibia with loosening.He was indicated for a semi urgent revision knee replacement.Upon making arthrotomy, there was evidence of massive synovitis with osteolytic tissue.The polyethylene was removed.There was evidence of bone loss on the tibia and the femur.Both the femur and the tibia were loose, but not grossly loose.Upon removing the femur, there was massive osteolysis with a giant cavitary defect with almost no condyles, just axial condyle.While trailing, the attention from the construct caused a fracture of the medial femoral condyle given how poor his bone quality was.No other issues or complications were reported.The patient was brought to the recovery room in stable condition.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failures.However, the reported prosthesis wear and loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no product information, images, radiographs, or relevant clinical information was provided.H6: corrected health effect and investigation clinical codes.

• Brand Name: LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T
• 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: 20745254
• Report Number: 1038671-2024-04457
• Device Sequence Number: 20985992
• Product Code: JWH
• UDI-Device Identifier: 10885862003263
• UDI-Public: 10885862003263
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 12/11/2024

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: 09/26/2017
• Device Catalogue Number: 02-012-41-5050
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 09/29/2012
• 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: 69 YR
• Patient Sex: Male