MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC TIBIAL PS MOD INSERT, SIZE 2, 15MM

Model Number	02-012-35-2015
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.
Event or Problem Description
Surgery was a poly exchange on (b)(6) 2019.The 15 mm that came out was worn anterior and on the post.Primary surgery date was (b)(6) 2018.Patient had laxity.Implanted a 19 mm ps insert.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of prosthesis wear due to third body wear, excessive flexion of the femoral component, and/or rotational mismatch between the femoral and tibial components.It is unclear if the prothesis wear may have contributed to the reported joint laxity or if this was likely due to patient related factors.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC TIBIAL PS MOD INSERT, SIZE 2, 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9168451
• Report Number: 1038671-2019-00497
• Device Sequence Number: 16837975
• Product Code: JWH
• UDI-Device Identifier: 10885862001757
• UDI-Public: 10885862001757
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: 02-012-35-2015
• Device Catalogue Number: 02-012-35-2015
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR