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U.S. Department of Health and Human Services

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

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SMARTSET GHV BONE CEMENT; SMARTSET GHV BONE 1.2 G GENTAMICIN TOBRAMYCIN Back to Search Results
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.
 
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Brand Name
SMARTSET GHV BONE CEMENT
Type of Device
SMARTSET GHV BONE 1.2 G GENTAMICIN TOBRAMYCIN
MDR Report Key5383936
MDR Text Key36631734
Report NumberMW5059518
Device Sequence Number1
Product Code MBB
Reporter Country CodeUS
Number of Events Reported1
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
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/14/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age60 YR
Patient Weight128
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