MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT TIB IMP CRC INSERT SZ 3, 13MM

Model Number	TRULIANT TIB IMP CRC INSERT SZ 3, 13MM
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Staphylococcus Aureus (2058); Rupture (2208)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.No information provided in the following section(s).
Event or Problem Description
Index surgery: (b)(6) 2019.Patient came to ed with left knee pain.Found to have quadriceps tendon rupture along with infected left tka.Elevated lab values indicated infection.Taken to or for i&d and revision left tka.(b)(6) cultures for mrse and (b)(6).Started on aneef and rifampin iv through picc for 6 weeks.The case report form indicates this event is definitely not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
The evaluation noted any ¿surgical site¿ infection noted in a patient that is greater than 3 months postop from a total joint surgical procedure is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself.(ref 1) it is noted that surgical intervention or revision along with infection is a known risk in any total joint surgery and may result in revision.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.
Event or Problem Description
As reported, a 64 y/o patient was initially implanted on (b)(6) 2019.Patient is 5¿4¿ and weighs 185lbs came to ed with left knee pain on (b)(6) 2019.Found to have quadriceps tendon rupture along with infected left tka.Elevated lab values indicated infection.Taken to or for i&d and revision left tka.Positive cultures for mrse and mssa.Started on iv antibiotics for 6 weeks.The patient has a history of primary osteoarthritis, hypertension, and chronic renal failure.The case report form indicates this event is definitely not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.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.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT TIB IMP CRC INSERT SZ 3, 13MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9184460
• Report Number: 1038671-2019-00510
• Device Sequence Number: 19597599
• Product Code: JWH
• UDI-Device Identifier: 10885862307651
• UDI-Public: 10885862307651
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 09/26/2026
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 3, 13MM
• Device Catalogue Number: 02-022-51-3013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 04/30/2020
• 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 Weight: 84