MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number TRULIANT TIB IMP PS INSERT SZ 5 9MM

Device Problems Misassembled (1398); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Approximately 4 years postop the initial ltsa, a surgeon ¿inherited¿ this (b)(6) y/o male patient and determined to complete a revision.The liner was disassociated from the tibial tray.On further inspection the feeling was it was not correctly locked into the posterior of the tray and was forced impacted in.The surgeon went from a size 5/9mm ps to a size 5/15mm ps insert.Patient was last known to be in stable condition following the event.The device will be returned.

Manufacturer Narrative

After further review of additional information received the following sections d9, g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of the tibial insert disassociating from the tibial tray, possibly due to incomplete seating of the tibial insert at the time of implantation, patient-related conditions, a post traumatic event, or any combination of these possibilities.The most probable root cause associated with the reported event of "disassembled / misassembled" is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.)l" is weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12503003
• MDR Text Key: 272435832
• Report Number: 1038671-2021-00488
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862304612
• UDI-Public: 10885862304612
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 5 9MM
• Device Catalogue Number: 02-022-35-5009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 92 KG