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	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial insert (cat# 204-22-09), tibial tray (cat# 200-04-23).Device evaluated by mfr: as reported by the exactech knee replacement study, approximately five years post tka, the patient experienced an infection.Patient is taken to the second time of review on (b)(6) 2019, a procedure without complications, discharged on (b)(6) 2019 continues antibiotic.The event is not related to the device or the procedure.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient conditions, which caused the infection.
Event or Problem Description
As reported by the exactech knee replacement study, approximately five years post tka, the patient experienced an infection.Patient is taken to the second time of review on (b)(6) 2019, a procedure without complications, discharged on (b)(6) 2019 continues antibiotic.The event is not related to the device or the procedure.

• 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
• MDR Report Key: 12737051
• Report Number: 1038671-2021-00568
• Device Sequence Number: 11794090
• Product Code: JWH
• UDI-Device Identifier: 10885862063182
• UDI-Public: 10885862063182
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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 Model Number: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2,
• Device Catalogue Number: 234-02-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/02/2021
• 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 Weight: 70