MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CC TIBIAL INSERT SZ 1, 15MM

Model Number	208-21-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Approximately 2 weeks after a previous right knee wash-out and the cck insert replacement, this female patient developed another infection.The cck insert was removed on (b)(6) 2020.The prosthesis was well fixed and showed no degree of movement was noted by the surgeon during the retrieval.Patient was last known to be in stable condition following the event.The devices will not return due to hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that 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 or is nosocomial in nature.Section(s): no information has been provided: a2, a4, a5, b6, b7, and d6.

• Brand Name: OPTETRAK
• Common Device Name: CC TIBIAL INSERT SZ 1, 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9848923
• Report Number: 1038671-2020-00248
• Device Sequence Number: 10944387
• Product Code: JWH
• UDI-Device Identifier: 10885862054111
• UDI-Public: 10885862054111
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• 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 Expiration Date: 12/02/2020
• Device Model Number: 208-21-15
• Device Catalogue Number: 208-21-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 03/18/2020
• 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