MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CC FEMORAL SIZE 4, RIGHT

Catalog Number 02-010-06-0340

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: screw (cn: unk, sn: unk).Tibial insert (cn: unk, sn: unk).

Event Description

It was reported that a (b)(6) male patient, who is 6'2" and weighs (b)(6) was initially implanted in (b)(6) 2019.The patient suddenly noted the right knee producing a squeaking noise approximately three weeks prior to this revision surgery.The femoral stem extension screw had subsequently become disassembled and fell into the joint space was confirmed with x-ray.As the surgeon operated on the patient with his typical revision exposure and proceeded to remove scar tissue and debride the joint, the loose screw was removed as well as the polyethylene insert.The joint was thoroughly washed with pulsatile lavage followed by installation of a new polyethylene insert and reinstallation of a new femoral stem extension screw.The femoral component and tibial tray were both well fixed and left in place.The operation was successful and there was no noted harm to the patient as a result of the loose screw and reportedly the patient is recovering well.The investigation is underway and the devices have been returned for analysis.

Manufacturer Narrative

Section h10: (h3) the evaluation noted that revision reported was likely the result of the surgeon impacting the stem extension multiple times after the femoral stem extension screw was tightened with the torque limiting driver during the first revision surgery.The multiple impactions may have caused the offset coupler to settle further into the taper, allowing the femoral stem extension screw to loosen, and subsequently disassemble from the femoral component.(d11) concomitant devices: (cn: 02-022-44-4015, sn: 5349581) - truliant tib imp psc insert sz 4, 15mm.No information provided in the following section(s): a5, b6, d4 (catalog number, serial number and expiration date, udi number), g5, and h4.The following section(s) have additional info: b3, b5, d1, d2, d4 (catalog number, serial number, exp date, and udi number) g4, g5, g7, h1, h2, h3, h4, h6, and h7.Section h11: corrections made in the following section(s): (b3) event date updated (d1) brand name (d2) common device name (d4) catalog number, serial number, exp date, and udi number (d11) concomitant devices updated (g5) 510k number (h4) manufacture date (h6) patient code has been updated.

Event Description

As reported, a 66 y/o male patient, who is 6'2" and weighs 230lbs was initially implanted in (b)(6) 2019.The patient suddenly noted the right knee producing a squeaking noise approximately three weeks prior to this revision surgery.The femoral stem extension screw had subsequently become disassembled and fell into the joint space was confirmed with x-ray.As the surgeon operated on the patient with his typical revision exposure and proceeded to remove scar tissue and debride the joint, the loose screw was removed as well as the polyethylene insert.The joint was thoroughly washed with pulsatile lavage followed by installation of a new polyethylene insert and reinstallation of a new femoral stem extension screw.The femoral component and tibial tray were both well fixed and left in place.The operation was successful and there was no noted harm to the patient as a result of the loose screw and reportedly the patient is recovering well.The investigation is underway and the devices have been returned for analysis.

• Brand Name: OPTETRAK LOGIC
• Type of Device: LOGIC CC FEMORAL SIZE 4, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9451936
• MDR Text Key: 170894214
• Report Number: 1038671-2019-00594
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K150890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/11/2022
• Device Catalogue Number: 02-010-06-0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 104