MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT KNEE COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3511
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-020-14-0335 - truliant cr por fem cr por right sz 3.5.(b)(6), 02-022-55-3535 - truliant por tib tray size 3.5f/3.5t.(b)(6), 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6), 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6), 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6), 201-78-15 - holding pin mini sharp point 4 pk.(b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk.(b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk.(b)(6), 521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(6), 521-78-36 - threaded pin size 5.1 collarless 2pk.05001221184, (b)(6) - gps implant kit v2.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported a patient underwent a right total knee arthroplasty.Subsequently, one (1) year post-op, the patient experienced pain and instability.It was noted the surgeon attempted a trial of bracing; however, approximately one (1) year later, the patient underwent a revision procedure of the tibial polyethylene component.No further impact to the patient was reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b2, h6, h11.A review of complaint history determined that no further action is required as no trends were identified.The reason for the reported revision due to instability in this event cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Subluxation and dislocation are known risks, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT KNEE COMPONENT
• 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: 22816833
• Report Number: 1038671-2025-02768
• Device Sequence Number: 21008425
• Product Code: JWH
• UDI-Device Identifier: 10885862307705
• UDI-Public: 10885862307705
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 05/04/2026
• Device Catalogue Number: 02-022-51-3511
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 126 KG