MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CC TIBIAL INSERT SZ 3, 30MM

Catalog Number	208-23-30
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: (cn: 204-04-33, sn: (b)(4)) trapezoid tibial tray sz 3f/3t, (cn: 208-23-11, sn; (b)(4)) cc tibial insert sz 3, 11mm, (cn: 204-34-12, sn: (b)(4)) fluted stem extension 120l x 14 mm.Pending engineering evaluation.
Event or Problem Description
Index surgery: (b)(6) 2018.A poly swap and washout was performed on (b)(6) 2019, but the infection persisted.
Additional Manufacturer Narrative
Section h10: (h3) the clinical evaluation noted based on review of all available information, the evidence suggest that the reported event is related to a infection 5 months post-op the implant.The cause of the revision is most likely is related to the patient¿s infection.
Additional Manufacturer Narrative
Section h10: (h3) the clinical evaluation noted based on review of all available information, the evidence suggest that the reported event is related to a infection 5 months post-op the implant.The cause of the revision is most likely is related to the patient's infection no information provided in the following section(s): a3, a5, b6.The following section(s) have additional info: b5, g4, g7, h1, and h2 section h11: corrections made in the following section(s): (b4) the event date was entered incorrect in the inital submission.Should be 10-apr-2019.

• Brand Name: OPTETRAK
• Common Device Name: CC TIBIAL INSERT SZ 3, 30MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9163646
• Report Number: 1038671-2019-00496
• Device Sequence Number: 19480855
• Product Code: JWH
• UDI-Device Identifier: 10885862054319
• UDI-Public: 10885862054319
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

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: 11/10/2018
• Device Catalogue Number: 208-23-30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/06/2019; 11/06/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/06/2019; 11/06/2019
• 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: 60 YR
• Patient Weight: 96