MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: (cn:200-02-32, sn: (b)(4) patella 32mm.
Event or Problem Description
Approximately 4 years postop the initial left tka, this (b)(6) y/o female patient with patient is 5¿4¿.(b)(6) pounds.Bmi 37.25, was revised to a badly worn poly insert.The device will be returned.Patient was last known to be in stable condition following the event.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision was likely the result of prosthesis wear which may have been due to a combination of third body wear, rotational mismatch between the femoral and tibial components, excessive tibial slope, and/or patient related factors.(d11) concomitant device: (cn:200-02-32, sn: (b)(6)) patella 32mm.No information provided in the following section(s): a5, and b6.The following section(s) have additional info: 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 13-jun-2020.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10214723
• Report Number: 1038671-2020-00323
• Device Sequence Number: 16674486
• Product Code: JWH
• UDI-Device Identifier: 10885862174413
• UDI-Public: 10885862174413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2011
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM
• Device Catalogue Number: 02-012-49-3009
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 98