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

Model Number	02-022-35-3510
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 2 years post op the initial right tka, this 67 y/o female patient was revised due the recall.Patient had a little bit of discomfort but no major problems.Surgeon went ahead and did a liner exchange and a tele exchange.Patient was last known to be in stable condition following the event.Device is not retuning, surgeon did not feel they needed to be sent back, there was no significant problems with the liner.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision was due to the device recall; no other reason was reported.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 2 years post op the initial right tka, this 67 y/o female patient was revised due the device recall.The patient had a little bit of discomfort but no major problems the surgeon did a liner exchange and a tele exchange.Revised were liner with a 3.5 /13 mm ps inserts and a new 32 patella.There were no reported issues during the surgical revision procedure.Patient was last known to be in stable condition following the event.Device is not retuning, surgeon did not feel they needed to be sent back, there was no significant problems with the liner.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.No additional information.
Event or Problem Description
As reported, approximately 2 years post op the initial right tka, this 67 y/o female patient was revised due the device recall.The patient had a little bit of discomfort but no major problems the surgeon did a liner exchange and a tele exchange.Revised were liner with a 3.5 /13 mm ps inserts and a new 32 patella.There were no reported issues during the surgical revision procedure.Patient was last known to be in stable condition following the event.Device is not retuning, surgeon did not feel they needed to be sent back, there was no significant problems with the liner.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, d1, d4 (remove all from initial report-suspect device unknown), g4 (remove erroneous date from initial report - 501k unknown) h6: clinical code, medical device code types of investigation and investigation findings.

• Brand Name: TRULIANT KNEE IMPLANTS
• 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: 15536390
• Report Number: 1038671-2022-01227
• Device Sequence Number: 12795439
• Product Code: JWH
• UDI-Device Identifier: 10885862304353
• UDI-Public: 10885862304353
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 10/14/2025

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 Model Number: 02-022-35-3510
• Device Catalogue Number: 02-022-35-3510
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 10/10/2025
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/08/2022; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female