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

Catalog Number	66017772
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a (b)(6)-year-old female patient underwent hip surgery for a medial femoral neck fracture on the right side.The palacos r+g 60g bone cement, which was stored at 20°c and mixed with palamix uno for 30 seconds, was applied 60 seconds after mixing.However, the cement set much faster than expected, hardening approximately 4 minutes after application.This rapid setting time was significantly shorter than usual.Consequently, the femoral stem could not be implanted, necessitating the removal of the hardened cement using chisels and drills and required an osteotomy.This led to an intraoperative delay of 180 minutes.
Additional Manufacturer Narrative
During a hip surgery, the customer noticed that the palacos r+g 60g cement hardened much too quickly, within about 4 minutes.This prevented the insertion of the stem.As a result, an osteotomy had to be performed and the hardened cement had to be removed using chisels and drilling, causing a 180-minute intraoperative delay.Despite this, the surgery was eventually completed successfully.Based on additional information, the bone cement was stored at 20°c and mixed with palamix uno for 30 seconds.It was applied 60 seconds after mixing.Four minutes post-application, the cement was too hard to place the hip implant.This occurred 5.5 minutes after mixing began.According to the ifu, the setting time starts at 5 minutes at 20°c with vacuum mixing and no pre-chilling.Therefore, the bone cement was used outside the allowed time frame.And the prosthesis was inserted too late.The batch documentation has been reviewed and no abnormalities were found.The quality control inspection was conducted according to specifications and revealed no irregularities.Both a customer sample and a retention sample were tested.However, the setting characteristics of bone cements such as palacos r+g are known to be sensitive to temperature conditions: if the operating room, mixing area, or storage temperatures are higher than recommended, this can accelerate the polymerization rate of the bone cement.If the bone cement is pre-chilled, the time it spends at room temperature before being mixed can significantly influence the working time.The temperature of the mixing tools, components, and even the humidity in the room can affect the setting time.In the ifu (1906_17644_palacos_r+g_gba_kartonierer_int.Indd 1 25.07.19 14:09) the following information is provided: "precautions: use by operating staff: before using palacos® r+g the user should be well acquainted with its properties, handling and application.The user is advised to practise the entire procedure of mixing, handling and introducing palacos® r+g before using it for the first time.Detailed knowledge is necessary even if mixing systems and syringes are being used for application of the cement.Mixing the components: it is advisable to first measure out the liquid and then add the powder.If this order is reversed, powder nests are more likely to form as a result of polymerisation commencing immediately at the surface.Both components, i.E.The relative proportions of powder and monomer, are precisely matched.The pouch and ampoule must therefore be emptied completely if an optimal mix is to be achieved.The components can be mixed with a vacuum mixing system or by hand.The mixing, waiting, working and curing times of palacos® r+g are shown in the diagrams at the end of the instructions for use.Please note that these are stated for guidance only because working time and curing time depend on temperature, mixing and humidity, whereby the direct ambient temperatures are important, e.G.Of cement powder, mixing system, bench and hands.A high temperature accelerates the waiting, working and curing times.Preparation with a vacuum mixing system: in order to obtain a bone cement with a reduced number of air inclusions, the liquid and the powder are mixed in a vacuum.For this purpose an airtight mixing system has to be used, ensuring that a sufficient vacuum builds up in the mixing vessel quickly (pressure approx.200 mbar absolute).It is recommended that the cement components be precooled at 4-7°c for at least 24 hours.The cement components should only be removed from the cooling vessel and filled into the mixing vessel just before mixing.Perform filling and mixing under sterile conditions.The mixing time is 30 seconds unless otherwise recommended.As a result of prior cooling the working time and curing time are longer.Initial viscosity is slightly reduced for palacos® r+g, compared to not pre-chilled cement.For details of mixing technique please refer to the instructions for the mixing system being used.Always mix the entire contents of a bag with the entire contents of an ampoule of monomer liquid.Use of the bone cement: the bone cement can be applied as soon as the doughy bone cement no longer adheres to the gloves.The application period depends on the temperature of the material and the room temperature.To ensure adequate fixation the prosthesis must be introduced and held within the time window allowed for working, until the bone cement has set completely.Remove any surplus cement as long as it is still soft.".

• Brand Name: PALACOS R+G
• Common Device Name: 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
• Manufacturer Contact: philipp-reis-strasse 8/13; wehrheim, hesse 61273
• MDR Report Key: 20923766
• Report Number: 3006406161-2024-12130
• Device Sequence Number: 13855577
• Product Code: MBB
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K202475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 66017772
• Device Lot Number: 70590059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female