MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	02-022-35-3013
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-020-11-0330 - truliant ps cem fem ps cem right sz 3 5143660.02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t 5508956.1510-s - cemex system fast 70 gm ab2786.200-02-35 - three peg patella 35mm 5534067.201-78-15 - holding pin mini sharp point 4 pk 5258889.201-78-82 - collar fixation pin 2pk 40mm, quick release 5509153.201-78-89 - 3" drill bit, mod.Hex 2 pack 3932952.201-78-89 - 3" drill bit, mod.Hex 2 pack 5512335.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2018.Approximately 3 years after the initial procedure the patient had a right knee revision on (b)(6) 2021.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2021: diagnosis: right total knee prosthetic instability.Inspection of the femoral and tibial metal implants was done after removal finding no evidence of erosion or loosening at any position.A 17 mm polyethylene trial was substituted finding the instability to be completely attended.The patient awakened and returned to the recovery room without complications.
Additional Manufacturer Narrative
Investigation results-the cause of the patient¿s instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.There is no mention in the operative report of device malfunction or wear, the tibial insert was increased in size.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
The 13mm insert was replaced with a 17mm to address the patient's knee stability.There is no mention of device malfunction or wear.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d10, h6 clinical codes, medical device problem code, component code and type of investigation code.D10: 02-020-11-0330 - truliant ps cem fem ps cem right sz 3 (b)(6).02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t (b)(6).1510-s - cemex system fast 70 gm (b)(6).200-02-35 - three peg patella 35mmm (b)(6).201-78-15 - holding pin mini sharp point 4 pk (b)(6).201-78-82 - collar fixation pin 2pk 40mm, quick release (b)(6).201-78-89 - 3" drill bit, mod.Hex 2 pack (b)(6).201-78-89 - 3" drill bit, mod.Hex 2 pack (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: michael crader ; 3523771140
• MDR Report Key: 17663270
• Report Number: 1038671-2023-02119
• Device Sequence Number: 6190424
• Product Code: JWH
• UDI-Device Identifier: 10885862304292
• UDI-Public: 10885862304292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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 Expiration Date: 03/29/2025
• Device Catalogue Number: 02-022-35-3013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 03/11/2024; 01/12/2026
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 03/11/2024; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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
• 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 H11.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown