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Stimulan® Rapid Cure 620-020 (UDI 50601557110416)Recalls & reported problems

Biocomposites Ltd · STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50601557110416), received between Mar 27, 2018 and Dec 23, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141830); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Compatibility Problem1
  • Microbial Contamination of Device1

Patient problems

  • Test Result2
  • Electrolyte Imbalance1
  • Failure of Implant1
  • Lethargy1
  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 23, 2019Microbial Contamination of Device

    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

    Patient problems: Failure of Implant; Lethargy; No Code Available; Test Result; Unspecified Infection

    MAUDE report 9510687 ↗
  • InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem

    PT EXPERIENCED HYPERCALCEMIA, WITH A CALCIUM LEVEL OF 13.9 (REF RANGE 8.3 - 10.4).FDA SAFETY REPORT ID#(B)(4).

    Patient problems: Test Result

    MAUDE report 9481960 ↗
  • InjuryMar 27, 2018Compatibility Problem; Compatibility Problem

    PATIENT PRESENTED WITH HYPERCALCAEMIA, POST OP.

    Patient problems: Electrolyte Imbalance

    MAUDE report 7372944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141830. One submission often covers many models, so check the product and lot details in each record.

  • Z-0638-2021 · Nov 12, 2020 · Terminated
    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

Other Filler, Bone Void, Calcium Compound devices

All Filler, Bone Void, Calcium Compound devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.