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

Model Number	02-010-03-0320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): tibial insert cr sz 2, 9mm (cat# 02-012-49-2009 / sn# (b)(4)), fit tibial tray cemented sz 2f/2t (cat# 02-012-45-2020 / sn# (b)(4)), three peg patella 35mm (cat# 200-02-32 / sn# (b)(4)), gps implant kit v2 (cat# a10012 / sn# (b)(4)).
Event or Problem Description
As reported, a (b)(6) female was initially implanted on (b)(6) 2016.On (b)(6) 2019 the patient was revised due to instability.The devices were disposed of by the hospital.The patient was last known to be in stable condition following the event.All available information has been received at this time.
Additional Manufacturer Narrative
(h3) the evaluation noted that as reported, a 63 y/o female was initially implanted on (b)(6) 2016.Approximately 3 years post-op, the patient was revised due to complaints of instability.The devices were disposed of by the hospital.The patient was last known to be in stable condition following the event.All available information has been received at this time.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.(d11) concomitant device(s): tibial insert cr sz 2, 9mm (cat# 02-012-49-2009 / sn# (b)(6)).Fit tibial tray cemented sz 2f/2t (cat# 02-012-45-2020 / sn# (b)(6)).Three peg patella 35mm (cat# 200-02-32 / sn# (b)(6)).Gps implant kit v2 (cat# a10012 / sn# (b)(6)).
Additional Manufacturer Narrative
Section h10: (d11) concomitant device(s): logic cr femoral cem, right, sz 2 (cat# 02-010-03-0320 / sn# (b)(6)).Fit tibial tray cemented sz 2f/2t (cat# 02-012-45-2020 / sn# (b)(6)).Three peg patella 35mm (cat# 200-02-32 / sn# (b)(6)).Gps implant kit v2 (cat# a10012 / sn# (b)(6)).

• 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: 9413286
• Report Number: 1038671-2019-00593
• Device Sequence Number: 2966406
• Product Code: JWH
• UDI-Device Identifier: 10885862158093
• UDI-Public: 10885862158093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2021

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: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: 02-010-03-0320
• Device Catalogue Number: 02-012-49-2009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 05/18/2020; 05/18/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 05/26/2020; 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR