MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 69 yo female patient, who was initially implanted on the right knee on (b)(6) 2021, underwent a poly swap revision surgery approximately 1 year 1 month post the initial implant procedure due to instability.They increased poly thickness from a 11mm ps insert to a 15mm psc insert and were revised to exactech devices.Patient was last known to be in stable condition following the event.Due to hospital policies, no products are available for return.No additional information is available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
Concomitant medical products: 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5, 6792590; 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t, 6531018; 200-02-35 - three peg patella 35mm, 6470897; 201-78-15 - holding pin mini sharp point 4 pk, 6790703; 521-78-23 - threaded pin size 2.3 collared 2pk, s265617; 521-78-31 - threaded pin size 2.6 collarless 2pk, s110679.No device returning due to hospital policies.Recall: z-2112 thru 2133-2021.
Additional Manufacturer Narrative
H7: z-0023-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d9, h6: medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15257980
• Report Number: 1038671-2022-00945
• Device Sequence Number: 6672001
• Product Code: JWH
• UDI-Device Identifier: 10885862304186
• UDI-Public: 10885862304186
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 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): 10/02/2025

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: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Device Catalogue Number: 02-022-35-2511
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 09/29/2025
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/13/2022; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female