MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CC FEMORAL SIZE 3, RIGHT

Model Number	02-010-06-0330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: (cn: 02-012-65-3013, sn: (b)(4)) logic cc tibial insert size 3, 13mm; (cn: 02-012-50-2013, sn: (b)(4)) logic fit / rbk augment 1\2 block rm/ ll size 2 10mm; (cn: 02-012-45-3020, sn: (b)(4)) logic tibial fit tray cemented sz 3f/2t; (cn: 02-012-50-2014, sn: (b)(4)) logic fit / rbk augment 1/2 block rl/lm size 2 10mm; (cn: 02-012-61-4000, sn: (b)(4)) logic offset stem ext coupler 4mm; (cn: 02-012-64-1312, sn: (b)(4)) truliant fluted stem ext 13mm x 120mm blast; (cn: 02-010-06-0330, sn: (b)(4)) logic cc femoral size 3, right; (cn: 02-012-61-6000, sn: (b)(4)) logic offset stem ext coupler 6mm; (cn: 02-012-64-1612, sn: (b)(4)) truliant fluted stem 16mm x 120 mm blast; (cn: 200-07-32, sn: (b)(4)) advanced patella 32mm 3 peg implant; (cn: 208-05-03, sn: (b)(4)) cc distal femoral augment size 3 5mm.
Event or Problem Description
As reported, this (b)(6) y/o female patient¿s initial right tka was a competitor¿s device, which was revised approximately 1year ago to this manufacture¿s tka.The patient was experiencing pain after her revision knee and was scheduled for a wash out/ poly exchange/ possible full revision knee.The patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the revision based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.(d11) concomitant device: - (cn: 02-012-65-3013, sn: (b)(6) logic cc tibial insert size 3, 13mm - (cn: 02-012-50-2013, sn: (b)(6) logic fit / rbk augment 1\2 block rm/ ll size 2 10mm - (cn: 02-012-45-3020, sn: 5812285) logic tibial fit tray cemented sz 3f/2t - (cn: 02-012-50-2014, sn: (b)(6) logic fit / rbk augment 1/2 block rl/lm size 2 10mm - (cn: 02-012-61-4000, sn: (b)(6) logic offset stem ext coupler 4mm - (cn: 02-012-64-1312, sn:(b)(6) truliant fluted stem ext 13mm x 120mm blast - (cn: 02-010-06-0330, sn: (b)(6) logic cc femoral size 3, right - (cn: 02-012-61-6000, sn:(b)(6) logic offset stem ext coupler 6mm - (cn: 02-012-64-1612, sn:(b)(6) truliant fluted stem 16mm x 120 mm blast - (cn: 200-07-32, sn: (b)(6) advanced patella 32mm 3 peg implant - (cn: 208-05-03, sn:(b)(6) cc distal femoral augment size 3 5mm no information provided in the following section(s): a4, a5, b6, the following section(s) have additional info: g4, g7, h1, h2, h3, h7.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CC FEMORAL SIZE 3, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10324141
• Report Number: 1038671-2020-00360
• Device Sequence Number: 2577480
• Product Code: JWH
• UDI-Device Identifier: 10885862265715
• UDI-Public: 10885862265715
• Combination Product (Y/N): N
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 11/20/2023
• Device Model Number: 02-010-06-0330
• Device Catalogue Number: 02-010-06-0330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: 76 YR