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Stimulan® Rapid Cure 620-010 (UDI 50601557110348)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
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50601557110348), received between Aug 30, 2016 and Jun 6, 2017 — classified as 1 injury, 1 malfunction.

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
  • Use of Device Problem1

Patient problems

  • Discharge1
  • Electrolyte Imbalance1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PHYSICIAN REPORTED TO DISTRIBUTOR A PATIENT WHO EXPERIENCED DRAINAGE 3-4 DAYS POST OP AFTER IMPLANTATION OF STIMULAN RAPID CURE 10CC, MIXED WITH 1 GRAM VANCOMYCIN, DRAINAGE WAS NOT EXPECTED.

    Patient problems: Discharge

    MAUDE report 6614399 ↗
  • MalfunctionAug 30, 2016Use of Device Problem; Compatibility Problem; Use of Device Problem; Compatibility Problem

    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.

    Patient problems: Electrolyte Imbalance

    MAUDE report 5913266 ↗

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.