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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial left tka, the 55 y/o female patient's original dos poly was revised from 2018 to a 15mm ps insert.The surgeon did a poly swap increased 4 mm of thickness from an 11mm to a 15mm.The surgeon stated tibial insert removed after 6 years was flawless.There was no wear or imperfections visible.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Image received.Sales rep was unable to obtain x-rays.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3): the reason for the revision reported cannot be confirmed from the information provided, but may be due to instability or inclusion of the implanted polyethylene in the packaging recall.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8 g1.The following sections were corrected: b2.D4: model number d10 concomitant devices: (b)(6), 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5, (b)(6), 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t, (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant, (b)(6), 201-78-82 - collar fixation pin 2pk 40mm, quick release.The reason for the revision reported cannot be confirmed from the information provided, but may be due to instability or inclusion of the implanted polyethylene in the packaging recall.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19000276
• Report Number: 1038671-2024-00689
• Device Sequence Number: 2997613
• Product Code: JWH
• UDI-Device Identifier: 10885862304186
• UDI-Public: 10885862304186
• 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: 2024
• 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): 01/16/2025

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 Expiration Date: 09/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 02-022-35-2511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/15/2024; 07/15/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/17/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• 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: 3" DRILL BIT, MOD. HEX 2 PACK (X3); ADVANCED PATELLA 32MM 3 PEG IMPLANT; COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE; SEE H11; TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5; TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female