MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2,
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 200-02-29, 2534733 - three peg patella 29mm, 204-04-22, 2624619 - trapezoid tibial tray sz 1f/2t, 2f/2t, 234-03-02, 2545850 - optetrak asy,ps cemented femoral, sz 2.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine years postop the initial rtka this (b)(6) female patient had an infection and surgeon performed a poly exchange with a wash out of the wound.Surgeon performed a patellaplasty and a poly exchange.Patient was last known to be in stable condition following the event.The device will not be returned as they were disposed by hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately nine years postop the initial rtka this 70 y/o female patient had an infection and surgeon performed a poly exchange with a wash out of the wound.Surgeon performed a patellaplasty and a poly exchange.Patient was last known to be in stable condition following the event.The device will not be returned as they were disposed by hospital.No additional information is provided.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2,
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville; 3523771140
• MDR Report Key: 12433384
• Report Number: 1038671-2021-00465
• Device Sequence Number: 12034012
• Product Code: JWH
• UDI-Device Identifier: 10885862063250
• UDI-Public: 10885862063250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 02/25/2021
• Device Model Number: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2,
• Device Catalogue Number: 234-03-02
• 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: 08/18/2021
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female