MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-022-51-3009

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitant devices: 03009021137 a10012 - gps implant kit v2 west, cynthia.5681453 02-020-14-0330 - truliant cr por fem cr por right sz 3 west, cynthia.6737458 201-78-98 - 2 pk, schanz pin, 4mm x 130mm west, cynthia.6841260 02-022-55-3020 - truliant por tib tray size 3f/2t west, cynthia.6907733 201-78-15 - holding pin mini sharp point 4 pk west, cynthia.S265322 521-78-32 - threaded pin size 3.0 collarless 2pk west, cynthia.S265534 521-78-32 - threaded pin size 3.0 collarless 2pk west, cynthia.S265576 521-78-23 - threaded pin size 2.3 collared 2pk west, cynthia.H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

Event Description

It was reported via legal documentation that a patient had a right knee replacement procedure on (b)(6) 2021 and then was revised on (b)(6) 2023.Patient required revision surgery for issues including but not limited to pain, swelling, scarring, numbness, inflammation, knee popping and clicking, instability, difficulty with activities of daily living.The mostly likely cause for the revision reported due to prosthesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3, 9MM
• Type of Device: 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 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19197057
• MDR Text Key: 341236543
• Report Number: 1038671-2024-00998
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862307637
• UDI-Public: 10885862307637
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/26/2024

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 Catalogue Number: 02-022-51-3009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• 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: SEE H10
• Patient Outcome(s): Required Intervention