MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0215
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 63 y/o female patient's left knee was revised.The initial procedure the implant became grossly loose.Patient was revised to a cc truliant femoral component with a stem.Patient was last known to be in stable condition following the event.No other patient information/medical history.Product not returning - implant was discarded during cleaning of instruments.X-ray attached.Unable to obtain photos.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6); 02-022-45-1515 - truliant tib fit tray cem sz 1.5f / 1.5t.(b)(6); 200-02-29 - three peg patella 29mm.(b)(6); 201-78-15 - holding pin mini sharp point 4 pk.(b)(6); 203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7.(b)(6); 521-78-23 - threaded pin size 2.3 collared 2pk.(b)(6); 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(6); 02-022-35-1509 - truliant tib imp ps insert sz 1.5, 9mm.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The extent and root cause of the femoral loosening could not be determined as the device was not returned for evaluation, and images were not provided.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17765347
• Report Number: 1038671-2023-02295
• Device Sequence Number: 12454426
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 10/01/2026

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: 02-020-11-0215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 10/01/2026
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/09/2024; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Female