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

Model Number	234-03-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the (b)(6) y/o female patient was initially implanted on (b)(6) 2016 by the exactech knee replacement study.The patient complained of an infection.Patient course with pain and findings of radiographic loosening is scheduled for revision on (b)(6) 2019, and is performed with prosthesis removal and placed spacer.The cultures report erysipelothrix rhusiopathiae and is consulted with infectiology and antibiotic management is initiated, a patient continues to be hospitalized.The event is not related to the device but related to the procedure.Devices are not returning and all available information received at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the based 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.No information provided in the following section(s): b6, d4 (serial number and exp number), h4.The following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• 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: 9699912
• Report Number: 1038671-2020-00070
• Device Sequence Number: 11215173
• Product Code: JWH
• UDI-Device Identifier: 10885862063267
• UDI-Public: 10885862063267
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: Health Professional
• Device Model Number: 234-03-03
• Device Catalogue Number: 234-03-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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: 76 YR
• Patient Weight: 73