MAUDE Adverse Event Report: SMARTSET GHV BONE CEMENT; SMARTSET GHV BONE 1.2 G GENTAMICIN TOBRAMYCIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Urinary Retention (2119); Vomiting (2144); Myalgia (2238); Test Result (2695)

Event Date 12/09/2015

Event Type  Injury  

Event Description

A (b)(6) male admitted for elective removal of left knee hardware because of a joint infection.He initially underwent a left total knee arthroplasty two months prior.A month after surgery, he then developed inflammation of the left knee and was taken to the operating room for irrigation and debridement.His wound culture grew (b)(6).He received ceftriaxone 2 grams iv daily for two weeks and then started developing redness of his left knee, therefore, had another irrigation and debridement and antibiotic beads were placed.Ceftriaxone was discontinued and he was started on daptomycin 800 mg iv every 24 hours.He then developed nausea, vomiting, myalgias, and cpk greater than 1000.Therefore, daptomycin, was discontinued and he was switched back to the iv ceftriaxone.Unfortunately at his follow up appointment it was felt that the patient's knee was still infected.He was then admitted for removal of left knee hardware with insertion of antibiotics spacers and given vancomycin 2 grams iv once before surgery and ketorolac 30 mg iv for severe pain in pacu.Postoperatively he developed hypotension and hypoxemia but he stabilized.An echocardiogram was performed which showed some small abnormalities of the aortic valve, possibly consistent with vegetation.The following day the patient was oligoanuric, and his bun and scr jumped from 9/0.73, 14/3.01, and then 19/3.75 (he had no previous renal insufficiency).His vancomycin kinetic level was 20.1.A tobramycin and gentamicin levels were checked in the event that the medication had systemically been absorbed.The tobramycin kinetic level was 5.8, and gentamicin was 0.3.Vancomycin was ordered and was dosed based off of levels.Over the next few days the patient's renal function started to stabilize, urine output started to pick up, and another tobramycin and gentamicin level were drawn which was 3.3 and 0.3.Reason for use: antibiotic spacers for infection.

• Brand Name: SMARTSET GHV BONE CEMENT
• Type of Device: SMARTSET GHV BONE 1.2 G GENTAMICIN TOBRAMYCIN
• MDR Report Key: 5383936
• MDR Text Key: 36631734
• Report Number: MW5059518
• Device Sequence Number: 1
• Product Code: MBB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 128