Model Number TRULIANT TIB IMP CRC INSERT SZ 3, 13MM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bacterial Infection (1735); Pain (1994); Staphylococcus Aureus (2058); Rupture (2208)
|
Event Date 07/05/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Pending engineering evaluation.No information provided in the following section(s).
|
|
Event 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.
|
|
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 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.
|
|
Search Alerts/Recalls
|