MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 3F / 2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-45-3020
Medical Device Problem Codes	Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Aseptic loosening (4883)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this female patient's tka was revised due to pain and synovitis.Tibial component was found loose.Patient left in stable condition with a new tibia implanted with stems and augments, and new 13mm psc insert.
Additional Manufacturer Narrative
Section h10: (d4) catalog number: 02-022-45-3020, serial number: (b)(6), expiration date: 16-jun-2029, unique identifier (udi) #: (b)(4).(d10) concomitant device(s): a10012, (b)(6) - gps implant kit v2.02-022-44-3013, (b)(6) - truliant tib imp psc insert sz 3, 13mm.02-020-11-0230, (b)(6) - truliant ps cem fem ps cem left sz 3.200-02-35, (b)(6) - three peg patella 35mm.201-78-15, (b)(6) - holding pin mini sharp point 4 pk.521-78-23, (b)(6) - threaded pin size 2.3 collared 2pk.521-78-36, (b)(6) - threaded pin size 5.1 collarless 2pk.521-78-32, (b)(6) - threaded pin size 3.0 collarless 2pk.521-78-32, (b)(6) - threaded pin size 3.0 collarless 2pk.(e1) first name: (b)(6).(h3) the revision reported may have been the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the tibial tray and subsequent pain.However, this cannot be confirmed because the component was not returned for evaluation.(h4) device manufacture date: 18-jun-2019 section h11: *the following sections have corrected information: (d1) brand name: truliant tib fit tray cem sz 3f / 2t.(h6) component code: 4755, part/component/sub-assembly term not applicable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: b1, b2, d6a, d8, g1, h6: clinical code, medical device problem code, component code, investigation findings, investigation conclusion.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 3F / 2T
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15087702
• Report Number: 1038671-2022-00832
• Device Sequence Number: 17152477
• Product Code: JWH
• UDI-Device Identifier: 10885862305817
• UDI-Public: 10885862305817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2026

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: 02-022-45-3020
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 07/10/2023; 02/23/2026
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 07/26/2023; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• 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 H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female