MAUDE Adverse Event Report: HERAEUS MEDICAL GMBH PALACOS R+G; ORTHOPAEDIC BONE CEMENT, MEDICATED

Catalog Number 66055102

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Hot Flashes/Flushes (2153)

Event Date 07/21/2023

Event Type  Injury  

Event Description

The patient underwent knee arthroplasty on (b)(6) 2023.After implantation of bone cement, the patient's blood pressure decreased to 75/50 mmhg, heart rate increased to 130 beats /min, and the skin was flushed.Chlormastine 1mg, epinephrine 0.5mg, methylprednisolone sodium succinate 40mg and other treatments were given.The patient had stable circulation, bp 125/63 mmhg, and heart rate 82 beats/min.The patient returned to the ward.

Manufacturer Narrative

It has been reported that a patient experienced a decrease in blood pressure to 75/50 mmhg, an increase in heart rate to 130 beats/min, and flushed skin following knee arthroplasty on (b)(6) 2023.The patient received treatment including chlormastine (an antihistamine) 1mg, epinephrine 0.5mg, methylprednisolone sodium succinate 40mg, and other interventions.After treatment, the patient's circulation stabilized with a blood pressure of 125/63 mmhg and a heart rate of 82 beats/min.The patient was then transferred back to the ward.This event is believed to be related to an allergic reaction, which is a known side effect.It is important to note that an allergic reaction to the components of the bone cement used during the procedure is a known side effect, and is addressed in the risk management file.The instructions for use (ifu) also provides information under the "contraindications" section, stating that "in cases of known hypersensitivity to the constituents of the bone cement palacos®r+g must not be used.".

• Brand Name: PALACOS R+G
• Type of Device: ORTHOPAEDIC BONE CEMENT, MEDICATED
• Manufacturer (Section D): HERAEUS MEDICAL GMBH; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer (Section G): HERAEUS MEDICAL GMBH; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• MDR Report Key: 17974640
• MDR Text Key: 326128241
• Report Number: 3006406161-2023-01020
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K202475N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66055102
• Device Lot Number: 64661217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 72 KG