MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PS TIBIAL INSERTS SZ 1, 11MM

Model Number	204-21-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported, approximately 11 years post the initial right tka, the patient presented with pain.The surgeon aspirated the knee and found infection.A revision was planned.The surgeon removed the knee joint and the poly liner.An i & d of the joint space was done and the joint was washed thoroughly, then a slightly smaller liner was placed.The joint was then closed, and the patient left the or in stable condition.
Additional Manufacturer Narrative
The evaluation noted that based upon on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: OPTETRAK
• Common Device Name: PS TIBIAL INSERTS SZ 1, 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9866029
• Report Number: 1038671-2020-00255
• Device Sequence Number: 2951855
• Product Code: JWH
• UDI-Device Identifier: 10885862048158
• UDI-Public: 10885862048158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: No Information
• Device Expiration Date: 09/02/2016
• Device Model Number: 204-21-11
• Device Catalogue Number: 204-21-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: 61 YR