MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM

Model Number	244-25-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); No Information (3190)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): (cn: 204-04-54, sn:(b)(4)) trapezoid tibial tray sz 5f/4t, (cn: 200-02-38, sn: (b)(4)) three peg patella 38mm.
Event or Problem Description
Original surgery was (b)(6) 2009.Worn poly, failed patella component.Removed patella, replaced tibial baseplate with a stemmed component and new insert.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that as reported, the 78 y/o male patient fell and damaged the patella.The surgeon determined a revision of failed patella component.Removal and replacement of the patella, replaced tibial baseplate with a stemmed component and new insert.Devices not returned.In a review of the labeling it is a known complication that a patient¿s age, weight, or activity level would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues and was most likely caused by the patient's fall.(d3) concomitant device(s): (cn: 204-04-54, sn:(b)(6) ) trapezoid tibial tray sz 5f/4t.(cn: 200-02-38, sn: (b)(6) ) three peg patella 38mm.
Event or Problem Description
As reported, the 78 y/o male patient fell and damaged the patella.The surgeon determined a revision of failed patella component.Removal and replacement of the patella, replaced tibial baseplate with a stemmed component and new insert.Devices not returned.There was no delay to surgery.

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9250383
• Report Number: 1038671-2019-00546
• Device Sequence Number: 2310791
• Product Code: JWH
• UDI-Device Identifier: 10885862064080
• UDI-Public: 10885862064080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 11/11/2012
• Device Model Number: 244-25-11
• Device Catalogue Number: 244-25-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 05/26/2020
• 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: 78 YR