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

Model Number	620-020
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Lethargy (2560); Test Result (2695); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): BIOCOMPOSITES LTD; keele science park; keele university; newcastle under lyme, keele ST5 5 NL; UK ST5 5NL
• MDR Report Key: 9510687
• Report Number: 9617083-2019-00007
• Device Sequence Number: 19578568
• Product Code: LOE
• UDI-Device Identifier: 50601557110416
• UDI-Public: 50601557110416
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 123765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: literature
• Initial 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 620-020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2019
• 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: Other