MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN RAPID CURE

Model Number	620-020
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The endocrinologist from (b)(6) hospital, made a request regarding the use of stimulan rapid cure with abx in pharmacology/pharmacokinetics and hypercalcaemia.Contact details for the on call surgeon consultant, were provided.The endocrinologist is based at the (b)(6) hospital centre, surgery was performed at (b)(6) medical centre, the patient developed hypercalcaemia after surgery and was transferred to (b)(6) hospital.The endocrinologist was consulted for a patient's hypercalcaemia.The implant was explanted.Confirmation was received from the endocrinologist that the hypercalcaemia had resolved.Surgery details, total joint reconstruction.Although the customer has been contacted on a number of occasions since, regarding case details and patient status, no response has been received and there is limited data available regarding the case.Although it has not been confirmed if the patient had renal instability prior to the case, stimulan rapid cure is contraindicated for use in renal compromised patients.Where antibiotic is locally administered following tissue debridement at infected surgical sites, caution should be exercised in the administration of the antibiotic dosing regime with particular attention to total antibiotic load, the patients' co-morbidities and administration of any nephrotoxic agents.The quantities and type of antibiotics used have not been confirmed.Some antibiotics are clinically known to be nephrotoxic which may have contributed to the patient's condition.Corrective action: the stimulan rapid cure was removed from the patient.Preventative action: a patients' medical history, physical and nutritional status, clinical condition and co-morbidities should all be carefully assessed and taken into consideration when planning an antibiotic regime.
Event or Problem Description
Patient presented with hypercalcaemia, post op.

• Brand Name: STIMULAN RAPID CURE
• Common Device Name: STIMULAN RAPID CURE
• Manufacturer (Section D): BIOCOMPOSITES LTD; keele science park; keele, ST5 5 NL; UK ST5 5NL
• MDR Report Key: 7372944
• Report Number: 9617083-2017-00003
• Device Sequence Number: 2023536
• Product Code: MQV
• UDI-Device Identifier: 50601557110416
• UDI-Public: 50601557110416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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 Expiration Date: 07/31/2020
• Device Model Number: 620-020
• Device Catalogue Number: 620-020
• Device Lot Number: 07/17-R335/344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention