MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM

Model Number	02-012-49-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Female, age (b)(6), bmi more than 35, initial implant of left knee (b)(6) 2018.(b)(6).Mr.(b)(6), our direct sales rep.Was consulted by dr.(b)(6) on (b)(6) 2020 about this revision case for the case that primary logic cr slope tka was performed on (b)(6) 2018.Excessive polyethylene wear on the medical compartment of the left insert was observed on the preoperative x-rays, the revision surgery for replacing the tibial insert was implemented on (b)(6) 2020.The surgery was finished without any problem.Surgeon will be monitoring post-operative outcome.At the time of the surgery, dr.(b)(6) observed severely damaged tibial insert as follows; 1.Remarkable delamination wear on the both medial and lateral articulating surfaces.2.Completely worn out posterior articulating surfaces.3.Clacks at the posterior under cut area for locking mechanism.4.Breakage of the central mushroom peg for locking mechanism on the backside.5.Broken fragments was already observed in the patient wound site when the surgeon opened the knee joint.He has experienced similar severe polyethylene wear of the cr slope++ inserts in other case, then we submitted the experience report ((b)(4)) on (b)(6) 2020.We have reported to him the result of the case review by exactech and the feed back and comments from the dr.(b)(6), one of the cr slope designing surgeons.He recognize that the cause of this excessive wear of tibial insert might be due to malignment of the tibial tray placement, tight flexion gap, degree of posterior slope cut of the tibia as per the investigation report by exactech and comments from dr.(b)(6), however, he now feels the durability of the cr slope ++ tibial inserts is skeptical, and he decided to use cr neutral tibial insert as his first choice when he uses logic knee.Further details about the background of this case.Please refer to the annex.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the reported event was likely the result of a combination of axial rotation mismatch secondary to malalignment of the tibial component and patient conditions which allowed for excessive posterior contact, especially medially, leading to wear and fracture of the polyethylene tibial insert.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10837207
• Report Number: 1038671-2020-00612
• Device Sequence Number: 19714371
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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?: No
• Operator of Device: No Information
• Device Expiration Date: 08/02/2019
• Device Model Number: 02-012-49-2009
• Device Catalogue Number: 02-012-49-2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR