MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the exactech truliant knee clinical study, approximately one months post initial lta, the 73 y/o female patient experienced arthrofibrosis.The patient states she "over did it" with hh on last visit and notes decreased range of motion (rom) and increased stiffness.Flex/ext -11/72.Follow-up with physician, mua scheduled (b)(6) 2020.The event was resolved on (b)(6) 2020 by left knee post tka manipulation performed.Per clinical study report, the reported event is unlikely related to the device but definite related to the procedure.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM
• Type of Device: 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: michael crader
• MDR Report Key: 18988074
• MDR Text Key: 338728041
• Report Number: 1038671-2024-00680
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862307576
• UDI-Public: 10885862307576
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM
• Device Catalogue Number: 02-022-51-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0023-2022
• Patient Sequence Number: 1
• Treatment: ADVANCED PATELLA 32MM 3 PEG IMPLANT.; TRULIANT CR CEM FEM CR CEM LEFT SZ 2.5.; TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White