MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,

Model Number	232-02-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: (cn: 200-02-35), sn: (b)(4) - three peg patella 35mm.(cn: 204-04-34), sn: (b)(4) - trapezoid tibial tray sz 3f/4t.(cn: 204-23-13, sn: (b)(4)) - ps tibial inserts sz 3, 13mm.
Event or Problem Description
As reported, approximately 5 years post-op the initial knee implant, a male patient, age and weight unknown, alleges that his implanted device failed and caused him bodily injury, some of which may be permanent in nature, suffered pain, emotional distress, and required additional surgical procedures to remove the defective device.It is unknown if the patient had all devices removed or if exactech devices were the revision devices.No other information available at this time.
Additional Manufacturer Narrative
This file was found to be a duplicate of 1038671-2020-00282.Please disregard this submission.
Additional Manufacturer Narrative
(h3) the evaluation of the of the reported event based upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions concomitant device: (cn: 200-02-35, sn: (b)(6)) - three peg patella 35mm; (cn: 204-04-34, sn: (b)(6)) - trapezoid tibial tray sz 3f/4t; (cn: 204-23-13, sn: (b)(6)) - ps tibial inserts sz 3, 13mm.

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10786885
• Report Number: 1038671-2020-00602
• Device Sequence Number: 16900450
• Product Code: JWH
• UDI-Device Identifier: 10885862063038
• UDI-Public: 10885862063038
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2021

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: 03/07/2017
• Device Model Number: 232-02-03
• Device Catalogue Number: 234-02-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 04/13/2021; 04/16/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 04/13/2021; 06/29/2021
• 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