FDA Adverse Event Injury Summary report: N

CERAMENT G

MDR report key: 24117762 · Received January 20, 2026

Report

Report Number
MW5182486
Event Type
Injury
Date Received
January 20, 2026
Date of Event
December 3, 2025
Report Date
January 11, 2026
Manufacturer
BONE SUPPORT AB
Product Code
QRR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD SURGERY ON (B)(6) 2025 IN HOSPITAL FOR SPECIAL SURGERY (HSS) WHERE CERAMENT-G WAS INSERTED IN A LARGE BONE DEFECT OF MY LEFT FEMUR TO TREAT CHRONIC OSTEOMYELITIS. I DEVELOPED HIGH FEVER 3 DAYS LATER, AND A VERY LARGE HEMATOMA WHICH WAS DRAINED AND SHOWED EXTREMELY HIGH CELL COUNT. (B)(6) 2025 CERAMENT WAS SURGICALLY REMOVED, INTRA OPERATIVELY THE SURGEON NOTED THAT THE CERAMENT LOOKED UNFORMED AND NOT NORMAL. STIMULAN WAS INSERTED IN ITS PLACE. CELL COUNT WAS ELEVATED TO 3,375 (B)(6) 2025 I SPIKED VERY HIGH FEVER 103 AND FELT VERY UNWELL AND ILL. I WAS READMITTED TO HSS ON (B)(6) 2025 WITH CONSTANT HIGH FEVERS, LOW BLOOD PRESSURE, HIGH WHITE COUNT. EMERGENCY SURGERY WAS PERFORMED ON (B)(6) 2025 WHERE THE STIMULAN WAS REMOVED AND EXTENSIVE WASHOUT WAS PERFORMED I CONTINUED TO DO DETERIORATE, ON (B)(6) 2025 WITH CONSTANT HIGH FEVERS OF 103, LOW BLOOD PRESSURE, LOW OXYGEN SATURATION. I WAS DIAGNOSED WITH A PNEUMONIA, LIVER FUNCTION WAS ABNORMAL, PANCREATIC FUNCTION WAS ABNORMAL. I FELT EXTREMELY WEAK AND UNABLE TO BREATH WELL. A RASH THEN BEGAN TO APPEAR WHICH WAS INITIALLY DIAGNOSED AS A HEAT RASH BY THE DERMATOLOGIST. HOWEVER, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS) EVENTUALLY BEGAN TO BE SUSPECTED AND I WAS PUT ON A REGIMEN OF STERIODS WHICH I RESPONDED WELL TO AND STILL RECOVERING FROM. IN SUMMARY, I DEVELOPED DRESS REACTION FROM CERAMENT-G AND STIMULAN, ORTHOPEDIC PRODUCTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
174103 CERAMENT G FILLER, BONE VOID, CALCIUM COMPOUND CONTAINING SINGLE APPROVED AMINOGLYCOSIDE QRR BONE SUPPORT AB

Patients

Seq Age Sex Outcome Treatment
1 56 YR Female Hospitalization| L| O| R