MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR FEMORAL POR, RIGHT, SZ 5

Model Number	02-010-04-0350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: gps implant kit v2 (cat# a10012 / sn# (b)(4)), logic cr tib insert slope++, sz 5, 9mm (cat# 02-012-49-5009 / sn# (b)(4)), lgc tibial fit tray cem sz 5f / 5t (cat# 02-012-45-5050 / sn# (b)(4)).
Event or Problem Description
As reported, male patient, age and weight are unknown.Revision of logic cr knee due to patella pain, patella to be resurfaced.Patient was last known to be in stable condition following the event.The devices are not available for evaluation as it disposed by hospital.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This event was determined to be a non-complaint as there is no evidence that the device failed to meet its specifications or to perform as intended.Please disregard.
Event or Problem Description
As reported, male patient, age and weight are unknown.Revision of logic cr knee due to patella pain, patient¿s anatomical patella to be resurfaced.Patient was last known to be in stable condition following the event.The devices are not available for evaluation as it disposed by hospital.Patient was last known to be in stable condition following the event.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR FEMORAL POR, RIGHT, SZ 5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9457679
• Report Number: 1038671-2019-00600
• Device Sequence Number: 14229001
• Product Code: JWH
• UDI-Device Identifier: 10885862158406
• UDI-Public: 10885862158406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 05/04/2022
• Device Model Number: 02-010-04-0350
• Device Catalogue Number: 02-010-04-0350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 06/24/2020
• 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