MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN; BONE VOID FILLER

Model Number 620-020

Device Problem Microbial Contamination of Device (2303)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Lethargy (2560); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A biocomposites clinical research director found a published paper on "symptomatic hypercalcaemia following the use of dissolvable antibiotic beads in infected total knee arthroplasty." sn comprehensive clinical medicine" by smith, b.L.And w.S.Borland.Within this paper, it states that a (b)(6) year old female patient developed hypercalcemia after a total knee replacement and underwent a prosthesis retraining procedure with the use of antibiotic loaded calcium sulphate beads.No product information has been provided, however it has been deduced that 20 cc of stimulant have been used.".40 cc of beads administered, which is double the quantity used for the patient in this case report" stimulant instructions for use stipulates the device should not be used if the patient has severe vascular or neurological disease.

Event Description

Published paper by benjamin l smith & w steven borland stated.The gold standard treatment for periprosthetic joint infections is currently a 2-stage revision procedure with the use of antibiotic beads or cement spacer.We report the case of an elderly lady who had an infected total knee replacement and underwent a prosthesis retaining procedure with the use of antibiotic loaded calcium sulphate beads (stimulant in this case).Postoperatively, she became profoundly hypercalcaemic and lethargic.After other causes were excluded, she was taken for surgical washout of the knee joint.This led to prompt normalisation of serum calcium levels and resolution of her symptoms.We recommend the need for routine pre- and postoperative serial calcium measurements when using antibiotic impregnated calcium sulphate beads and that all doctors have an increased awareness of this risk.

• Brand Name: STIMULAN
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): BIOCOMPOSITES LTD; keele science park; keele university; newcastle under lyme, keele ST5 5 NL; UK ST5 5NL
• Manufacturer (Section G): BIOCOMPOSITES LTD; keele science park; keele university; newcastle under lyme, keele ST5 5 NL; UK ST5 5NL
• Manufacturer Contact: lyle robertson ; keele science park; keele university; newcastle under lyme, keele ST5 5-NL ; UK ST5 5NL
• MDR Report Key: 9510687
• MDR Text Key: 189067630
• Report Number: 9617083-2019-00007
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 50601557110416
• UDI-Public: 50601557110416
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 620-020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR