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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERAEUS MEDICAL LLC PALACOS R+G; BONE CEMENT, ANTIBIOTIC

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HERAEUS MEDICAL LLC PALACOS R+G; BONE CEMENT, ANTIBIOTIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erythema (1840); Fungal Infection (2419); No Code Available (3191); Renal Impairment (4499)
Event Date 03/31/2018
Event Type  Injury  
Event Description
This case demonstrates elevated serum creatinine in a patient with no history of kidney disease, elevated vancomycin level, and detectable tobramycin level without systemic tobramycin given in a patient after placement of a gentamicin impregnated cement palacos r+g with the incorporation of additional antibiotic powder.Patient was admitted for left prosthetic knee infection and underwent explantation of left prosthetic joint and insertion of a gentamicin impregnated cement (palacos r+g) on (b)(6) 2018.Two packets of palacos r+g cement were mixed with 7g of vancomycin powder and 4.8 grams of tobramycin power.Seven and a half hours after the procedure was completed, the patient was started on iv vancomycin 2g (17 mg/kg) every 12hr and iv cefepime 2g every 12hr.The patient did not have any history of kidney disease.On (b)(6) 2018, a vancomycin trough was drawn 1 hr prior to 4th dose, which resulted at 50.4 mcg/ml with a serum creatinine (scr) of 1.6 mg/dl.Iv vancomycin was discontinued and changed to iv daptomycin 6 mg/kg daily due worsening renal function, elevated vancomycin level, and intra-operative cultures growing enterococcus faecalis.The patient's scr continued to rise: (b)(6) 2018 scr 1.9 mg/dl, (b)(6) 2018 scr 1.8 mg/dl, and (b)(6) 2018 scr 1.5.Although renal function did not recover to her baseline, the patient was discharged on post-op day 6, (b)(6) 2018, with a scr of 1.3 mg/dl, to continue iv daptomycin for 6 weeks.As an outpatient, the frequency of iv daptomycin was decreased to every other day due to worsening renal function and elevated creatine kinase.Around (b)(6) 2018, the patient started to experience increased redness at the surgical incision area that was warm to the touch and a formation of a small bullae.Superficial wound cultures were taken and showed growth of candida albicans.Due to worsening renal function and the growth of c.Albicans from her wound culture, the patient was asked to return to the emergency room for further evaluation and hospital admission on (b)(6) 2018.It was noted in the emergency room that the patient had worsening renal function with her scr up to 2.3 mg/dl.The patient was given one dose of iv anidulafungin 200 mg to cover c.Albicans from the outpatient wound culture then started on iv ampicillin/sulbactam 3g every 6 hours to cover e.Faecalis that was cultured during her previous admission.On (b)(6) 2018, the antibiotics was empirically broadened to iv zosyn 2.25g every 8hr and iv fluconazole 200 mg daily was added.On (b)(6) 2018, her scr was 1.4 and a random tobramycin level was obtained, which resulted at <0.4 mcg/ml.On (b)(6) 2018, she underwent a second procedure with exchange of the left knee antibiotic cement spacer.Two packets of palacos r+g cement were again mixed with 3g of vancomycin powder and 3.6 grams of tobramycin power.She continued on iv zosyn and iv fluconazole after the procedure while intra-operative cultures were pending.On (b)(6) 2018, another random tobramycin level was obtained and resulted at 1.4 mcg/ml although no tobramycin was given iv.On (b)(6) 2018, post-op day 6, the patient was discharged with a scr of 1 mg/dl.Fda safety report id# (b)(4).
 
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Brand Name
PALACOS R+G
Type of Device
BONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
HERAEUS MEDICAL LLC
MDR Report Key10586012
MDR Text Key208764151
Report NumberMW5096849
Device Sequence Number1
Product Code MBB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
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
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age58 YR
Patient Weight53
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