MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2018.Approximately 4 years and 5 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.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.Revision op report on (b)(6) 2018: diagnosis: failed right total knee findings: there was found to be a clean wound with clear synovial joint fluid.There was a copious amount of capsular scar tissue from polyethylene reaction.The polyethylene insert was removed and there was found to be visible polyethylene wear within the poly tray.There was severe osteolysis around the distal femur and proximal tibia with a loose femoral component.The femoral component was found to be completely loose from the cement mantle with cement still adhered to the distal femur with osteolysis of the bone on the back side of the cement.There was a partially fixed tibial tray with osteolysis underneath the tibial tray.The patellar component was also revised.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(6), 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5.(b)(6), 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t.(b)(6), 200-02-32 - three peg patella 32mm.(b)(6), 204-70-00 - tibial stem ext.Screw.Pending investigation.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening and femoral 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.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 13MM
• 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 ; gainesville 32653
• MDR Report Key: 18028074
• Report Number: 1038671-2023-02627
• Device Sequence Number: 7017956
• Product Code: JWH
• UDI-Device Identifier: 10885862304384
• UDI-Public: 10885862304384
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2026
• Device Catalogue Number: 02-022-35-3513
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/16/2025
• Date Device Manufactured: 01/11/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female