MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC TIBIA PS MOD INSRT SZ 2 9MM

Model Number 02-012-35-2009

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

The evaluation pending.

Event Description

As reported, this patient presented with a laxity issue approximately three years postop from a tka.The patient¿s poly liner was revised from a 9mm to a 15mm.The 9mm poly was worn.The device will be returned.Initial implant date: (b)(6) 2016.Doe (b)(6) 2020.

Manufacturer Narrative

Section h10: (h3) the evaluation noted that the revision was most likely the result of prosthesis wear secondary to soft tissue laxity and possible implantation of the femoral component in internal rotation which likely contributed to larger than normal femoral-tibial rotation throughout the range of motion and increased medial compartment pressure during flexion that accelerated damage to the polyethylene insert.No information provided in the following section(s): a5, and b6.The following section(s) have additional info: a2, a3, a4, d10, g4, g7, h1, h2, h3, and h7.Section h11: corrections made in the following section(s): (g4) the awareness date in the initial submission should have been 20-jan-2020.

• Brand Name: OPTETRAK LOGIC
• Type of Device: LOGIC TIBIA PS MOD INSRT SZ 2 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9665964
• MDR Text Key: 189096995
• Report Number: 1038671-2020-00019
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001726
• UDI-Public: 10885862001726
• Combination Product (y/n): N
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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 Expiration Date: 06/23/2020
• Device Model Number: 02-012-35-2009
• Device Catalogue Number: 02-012-35-2009
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74