MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-35-4017
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: femoral serial no.(b)(6).Patella serial no.Unk.Tibial tray serial no.(b)(6).
Event or Problem Description
It was reported via clinical study, that the 60 yo male patient experienced a patellar sleeve fracture which presents as clicking laterally with flexion but is not painful.The date of adverse event onset is unk-unk-2018.The patient was revised on (b)(6) 2022 with the outcome last known as resolved.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2022-01521.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16587654
• Report Number: 1038671-2023-00474
• Device Sequence Number: 1688401
• Product Code: JWH
• UDI-Device Identifier: 10885862247414
• UDI-Public: 10885862247414
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 01/08/2022
• Device Catalogue Number: 02-012-35-4017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2023
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 143 KG