MAUDE Adverse Event Report: HERAEUS MEDICAL GMBH PALACOS R+G PRO 75; ORTHOPAEDIC BONE CEMENT, MEDICATED

Catalog Number 66044274

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that monomer liquid did transfer to the powder and that the cement was injected at around 2 minutes.At 4 minutes when the stem was inserted, the cement was already too hard to position the stem exactly.At 6.5 minutes the cement was completely hardened.The cement and the stem had to be removed, and a shorter stem was implanted with a new pro set.According to the responsible sales representative, the cement is stored at 18°c and the or is mostly around 19°c.The batch record review of the batch in question did not reveal any abnormalities.Also, the complaint text also does not allow any conclusions to be drawn about a product anomaly.There are different aspects, such as storage conditions, room temperature, humidity, bone cement components (complete monomer transfer), mixing device, and mixing technique, which can have an impact on application and curing phases.Thereby, curing times can differ.This does not affect the mechanical properties of the product.In this case the cement was injected at around 2 minutes and the stem was inserted at 4 minutes.This indicates that the user was presumably working too slow.According to the diagram in the end of the instructions for use of palacos r+g pro (that shows working reference values under laboratory conditions), the application phase for the cement at a room temperature of 19°c starts at 1 minute and the setting phase starts about 5 minutes.In the instructions for use of palacos r+g pro it is stated that the user has to familiarize himself/herself with the device prior to its use.Excerpt form 1906_17653_palacos_r+g_pro_gba_kartonierer_int.Indd : precautions: use by operating theatre staff, "before using palacos® r+g pro the user must be well-acquainted with its properties, handling and application.Within the scope of a familiarisation session, the user is advised to practice the entire procedure of mixing, handling and introducing palacos® r+g before using it for the first time." preparation and mixing: "[.] the mixing times, waiting times, working times and curing times of palacos® r+g pro are shown on the diagram at the end of theses instructions.Please note that they are stated for guidance only, because the working time and curing time depend on temperature, mixing and humidity, whereby direct ambient temperatures also have an influence.Higher temperatures or high humidity shorten the waiting, working and curing times.It is not recommended to pre-cool palacos® r+g pro.The initial viscosity of pre-cooled palacos® r+g is lower than that of a bone cement that has not been pre-cooled and the processing time is significantly prolonged.If palacos® r+g pro is used pre-cooled the user is strongly recommended to familiarise themselves in advance with the pre-cooled product in terms of the initial viscosity, as well as waiting, application and curing times." thus, the event is assessed as user error with serious outcome.The event "application outside the defined time frame" is also encompassed in the rmm of the device: 23293_hme-rmf_risk_management_matrix_palacosr+gpro_mv+gpro rev01 h02.5.Hazard: preparation- / use of the device outside of the defined time frame(s) hazardous situation: application of the bone cement outside of the defined time frame.Loosening of the prosthesis.Potential harm: revision of the prosthesis.

Event Description

Information received via heraeus product experience report: scrub nurse does prepare pro-set lot x101 - she breaks the ampoule by pushing the lever down (till stop point) - she pushes the foot pedal - liquid did transfer to the powder - she starts mixing - when giving the mixture to the surgeon - he starts cementing the femur for a hip-stem and the bone cement already cured at 4' - the stem wasn't positioned exact at that time, so they had to do a revision already , strong delay in surgery > 30 minutes - surgeon was very irritated - this pro-set was already thrown away by circulation nurse (no pictures).A 2nd pro set was taken and this worked well.The nurse is a very well known nurse for mixing pro-sets.Information received via heraeus questionnaire form: patient: male, 91y/o, 90kg, 180cm.Indication for surgery: coxarthrosis.Operation date: (b)(6) 2023.Duration: 2h.Implants used: hip, polished tapered stem.Preparation of implantation site: pulse lavage.Method of cement application: retrograde filling with pressurisation.Medullary plug: resorbable.Description of event:.Normal mixing.Injection @ 2'.Implantation @ 4'.Full hardening @ 6.5'.Surgical step taking place at time of event: insertion of femoral stem.Type of complication: no full insertion of component possible.Post-operative treatment: no different postop measurements.Health impact: longer or time.Casuality seen by healthcare professional: yes.Due to quicker hardening a removal of cement, longer or time and shorter implant needed to be undertaken.Information received via sales representative: for the storage of palacos pro it is always at 18 degrees.They have a "wine cooler" to storage our pro's and take the pro-set out just before cementing time.The or is mostly around 19 degrees.

• Brand Name: PALACOS R+G PRO 75
• 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: 17772136
• MDR Text Key: 323692641
• Report Number: 3006406161-2023-00919
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66044274
• Device Lot Number: X101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 91 YR
• Patient Sex: Male
• Patient Weight: 90 KG