MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN RAPID CURE

Model Number	620-010
Medical Device Problem Codes	Use of Device Problem (1670); Compatibility Problem (2960)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	07/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mixing with other substances is a physician directed use.The quantity of tobramycin antibiotics used have not been confirmed.Stimulan rapid cure is contraindicated for use in patients with severe degenerative bone disease.The batch manufacturing record was reviewed and no contributory factors were identified.Although the customer has been contacted on a number of occasions since regarding patient status there is limited data available.The patient was receiving calcium supplementation (for osteoporosis) and triamterene/hctz (for hypertension).Both medications were discontinued per the recommendation of the clinical pharmacist; confirmation cannot be obtained as to whether this was prior to surgery or after.The clinical coordinator's report also states patient was given both pamidronate and calcitonin via iv.Triamterene is a potassium-sparing diuretic used in combination with thiazide diuretics for the treatment of hypertension and edema.In combination with hydrochlorothiazide (hctz).One of the side effects of diuretics can be that the salt balance in the bloodstream is sometimes upset which can cause a low blood level of potassium, sodium, and magnesium, and a high level of calcium.It is possible that the combination of treatments including calcium supplements contributed to hypercalcemia.Corrective action: although the patient had exhibited hypercalcaemia initially post surgery, details of the current patient status have not been provided by the customer.Calcium levels are being monitored daily.Device not returned to manufacturer.
Event or Problem Description
The hospital's clinical coordinator reported that a patient who had undergone hip revision surgery was presented with hypercalcemia, 1 day post op after implantation of stimulan rapid cure.The surgeon elected to mix tobramycin antibiotics with stimulan.The 30cc of stimulan was mixed with tobramycin (of unknown qty) and then implanted as beads.The beads are mixed in the or, so the pharmacist cannot confirm the volume implanted.Hypercalcemia presented (b)(6) 2016, corrected calcium level 13.6.

• Brand Name: STIMULAN RAPID CURE
• Common Device Name: STIMULAN RAPID CURE
• Manufacturer (Section D): BIOCOMPOSITES LTD; keele science park; keele, staffs ST5 5 NL; UK ST5 5NL
• MDR Report Key: 5913266
• Report Number: 9617083-2016-00002
• Device Sequence Number: 620315
• Product Code: MQV
• UDI-Device Identifier: 50601557110348
• UDI-Public: 50601557110348
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2016

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: 03/31/2019
• Device Model Number: 620-010
• Device Catalogue Number: 620-010
• Device Lot Number: 03/16-R283/284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2016
• Initial Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOBRAMYCIN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR