ACM 0306573000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540055415), received between Jul 27, 2020 and Oct 30, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 7, 2023Open, Classified

   Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

   Z-2600-2023 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 9, 2017Terminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1248-2018 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BHA, WHEN A SURGEON WAS INJECTING BONE CEMENT, THE NOZZLE CAME OFF FROM THE SYRINGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424455 ↗
• MalfunctionJan 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207624 ↗
• MalfunctionJul 26, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CEMENT MIXER WAS EXPIRED, IT WAS USED IN SURGERY WITH PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837099 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DEVICE WAS LEAKING BETWEEN THE CARTRIDGE AND THE NOZZLE DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855981 ↗
• MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 8 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397204 ↗
• InjuryJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE NOZZLE OF THE CEMENT MIXING BOWL WAS NOT ABLE TO BE CONNECTED PROPERLY CAUSING A DETACHMENT AND FINALLY A LEAKAGE OF CEMENT OUT THE GUN AND THEREFORE IT HAD TO BE APPLIED BY HAND. THE PROCEDURE WAS COMPLETED BY PLACING THE CEMENT BY HAND; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164620 ↗
• InjuryJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE REPORTED EVENT OCCURRED DURING A RIGHT HEMI HIP PROCEDURE WITH A CEMENTED STEM. THE CEMENT WAS MIXED AND THE ACM DELIVERY SYSTEM WAS USED TO BEGIN INJECTION OF THE CEMENT INTO THE MEDULLARY CANAL. DURING CEMENT INJECTION, THE NOZZLE OF THE ACM CAME OFF. THE SURGEON RE-ATTACHED THE NOZZLE OF THE ACM, WHICH TOOK 1-2 MINUTES. THE SURGEON WAS ABLE TO INJECT THE REMAINING VIABLE CEMENT IN THE ACM AND CONTINUED WITH THE PROCEDURE. IT WAS REPORTED THERE WERE CHALLENGES WHEN PLACING THE SIZE 5 STEM, AS IT WAS SITTING 2CM PROUD. THE SURGICAL PROCEDURE REQUIRED MODIFICATION AND BECAME MORE COMPLEX WHEN THE SURGEON REMOVED THE IMPLANT AND USED A CURETTE TO RETRIEVE CEMENT FROM THE CANAL. ALL CEMENT THAT HAD BEEN INJECTED COULD NOT BE REMOVED. A SIZE 2 IMPLANT WAS PLACED, WHICH SAT 1CM PROUD. THE SIZE 2 STEM WAS THEN REMOVED. THESE STEPS OF THE SURGICAL PROCEDURE OCCURRED OVER APPROXIMATELY 60 MINUTES, AT WHICH POINT THE PROCEDURE WAS CONCLUDED WITHOUT A STEM BEING IMPLANTED. IT WAS REPORTED THE PATIENT HAD DEVELOPED AN UNSPECIFIED CARDIAC ISSUE AND LATER EXPIRED. THIS REPORT IS FOR THE MALFUNCTION OF THE ACM NOZZLE DETACHING DURING USE, AND THE ASSOCIATED MEDICAL INTERVENTION. MFR REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050312 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802916 ↗
• MalfunctionJul 27, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10329745 ↗