MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint effusion (4849)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op initial left tka, this 74 y/o male patient was revised due to a loose femur and recalled poly.Patient complained of pain.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 521-78-23 - threaded pin size 2.3 collared 2pk 4976625.521-78-31 - threaded pin size 2.6 collarless 2pk 4915628.02-020-11-0350 - truliant ps cem fem ps cem right sz 5 4876544.02-022-35-5011 - truliant tib imp ps insert sz 5 11mm 4906188.02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t 4894512.200-07-35 - advanced patella 35mm 3 peg implant 4869655.201-78-15 - holding pin mini sharp point 4 pk 4961600.201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack 4558913.02-020-11-0250 - truliant ps cem fem ps cem left sz 5 (b)(6).02-022-35-5013 - truliant tib imp ps insert sz 5 13mm 4850786.02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t 5042422.200-07-35 - advanced patella 35mm 3 peg implant 5441520.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: b, c, d, e the reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, the reported pain, 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 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 PS CEM FEM PS CEM LEFT SZ 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: 17097027
• Report Number: 1038671-2023-01301
• Device Sequence Number: 11259775
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 Catalogue Number: 02-020-11-0250
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male