MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 5F / 5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-45-5050
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had left knee revision, approximately 62 months after their initial procedure.There was found to be a loose tibial component with a completely loose tibial stem.There was found to be a moderate amount of polyethylene wear within the tibial polyethylene.There was evidence of polyethylene wear and synovial encapsulation.There was a heterotopic bone formed around the patella with a loose patellar component.The patient also had developed a pretibial ganglion cyst due to the loose tibial component rubbing up against the anterior cortex of his mid left tibia.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
1038671-2023-01346.D10: concomitants: (b)(6), 660-01-10 - ossilix / form 10cc calcium phosphate; (b)(6), 02-012-60-2012 - tru stem ext 20mm x 120mm; (b)(6), 02-010-06-0250 - tru cc femoral size 5 left; (b)(6), 208-05-05 - cc distal fem augment sz 5, 5mm; (b)(6), 02-010-06-0551 - tru post.Aug.Size 5, 5mm; (b)(6), 02-010-06-0551 - tru post.Aug.Size 5, 5mm; (b)(6), 02-012-61-4000 - tru offset stem ext coupler, 4mm; (b)(6), 208-05-05 - cc distal fem augment sz 5, 5mm; (b)(6), 200-02-38 - three peg patella 38mm; (b)(6), 02-012-60-1212 - tru stem ext 12mm x 120mm; (b)(6), 204-70-00 - tibial stem ext.Screw; (b)(6), 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, patellar loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images 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: TRULIANT TIB FIT TRAY 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: 20745757
• Report Number: 1038671-2024-04459
• Device Sequence Number: 8614114
• Product Code: JWH
• UDI-Device Identifier: 10885862305947
• UDI-Public: 10885862305947
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 11/21/2024

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 Catalogue Number: 02-022-45-5050
• 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: 05/18/2023
• Initial Report FDA Received Date: 11/21/2024
• Date Device Manufactured: 10/27/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male