SMARTMIX CEMVAC 83-1615Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295202493), received between Jun 22, 2020 and Sep 10, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY FOR THE FEMUR WITH THE CEMENT, THE SYRINGE, AND THE OTHER COMPANY¿S CEMENT STEM. THE SURGEON PLANNED TO PUT THE THREE CEMENTS IN THE SYRINGE AND AGITATED THEM. THE SURGEON PREPARED AS PER THE PROCEDURE MANUAL AND PUT THE CEMENTS IN THE SYRINGE. HOWEVER, THE CEMENT POWDER WAS STUCK IN THE SYRINGE NOZZLE, AND THE SURGEON COULD NOT PUT THE ONE PACK OF THE CEMENT IN THE SYRINGE. THEREFORE, THE SURGEON USED THE OTHER COMPANY¿S CEMENT. SURGICAL DELAY OF 30 MINUTES OCCURRED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15397569 ↗
• MalfunctionNov 21, 2021Chemical Problem; Chemical Problem

  TODAY WE MIXED A BATCH OF SMART SET GHV BONE CEMENT AND THE SCRUB NURSE COULD NOT PUSH THE WHITE PUSHER INTO THE TOP OF THE SMARTMIX CEMVAC MIXING SYSTEM. WHEN SHE EVENTUALLY GOT IT IN AND MIXED THE CEMENT IT LOOKED LOOKED LUMPY INSTEAD OF SMOOTH. THIS WAS NOT USED AND WE TRIED AGAIN WITH A NEW MIX. WE HAD THE SAME ISSUE WITH THE WHITE ROD IN THE TOP OF THE MIXER BUT THE MIX LOOKED BETTER. HOWEVER WHEN WE WENT TO USE IT STAYED RUNNING AND STICKY FOR A LONGER TIME THAN NORMAL (APPROX 5 MINUTES) AND WAS NOTICED THAT THERE WERE SMALL LUMPS. THE SURGEON WASN'T HAPPY TO CONTINUE. WE THEN MIXED A THIRD BATCH OF CEMENT FROM A DIFFERENT SUPPLIER (CEMENT AND MIXING SYSTEM). 15 MINUTE SURGICAL DELAY. SURGERY SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 12850112 ↗
• MalfunctionNov 21, 2021Chemical Problem; Chemical Problem

  TODAY WE MIXED A BATCH OF SMART SET GHV BONE CEMENT AND THE SCRUB NURSE COULD NOT PUSH THE WHITE PUSHER INTO THE TOP OF THE SMARTMIX CEMVAC MIXING SYSTEM. WHEN SHE EVENTUALLY GOT IT IN AND MIXED THE CEMENT IT LOOKED LUMPY INSTEAD OF SMOOTH. THIS WAS NOT USED AND WE TRIED AGAIN WITH A NEW MIX. WE HAD THE SAME ISSE WITH THE WHITE ROD IN THE TOP OF THE MIXER BUT THE MIX LOOKED BETTER. HOWEVER WHEN WE WENT TO USE IT STAYED RUNNING AND STICKY FOR A LONGER TIME THAN NORMAL (APPROX 5 MINUTES) AND WAS NOTICED THAT THERE WERE SMALL LUMPS. THE SURGEON WASN'T HAPPY TO CONTINUE. WE THEN MIXED A THIRD BATCH OF CEMENT FROM A DIFFERENT SUPPLIER (CEMENT AND MIXING SYSTEM). 15 MINUTE SURGICAL DELAY. SURGERY SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 12850111 ↗
• MalfunctionJun 22, 2020Chemical Problem; Appropriate Device Problem Term/Code Not Available; Chemical Problem; Appropriate Device Problem Term/Code Not Available

  SMARTSET GHV WAS USED TO CEMENT AN ATTUNE TOTAL KNEE USING THE SMARTSET CEMVAC VACUUM MIXING SYSTEM. WHILE USING THE CEMENT, IT APPEARED TO GO OFF (HARD) QUICKER THAN EXPECTED (AT APPROX. 4-5 MINUTE MARK. CEMENT WAS MIXED AS PER PROPER TECHNIQUE, THE CEMENT HAD BEEN HOUSED IN THE THEATRE FOR PRECEDING 3-4 HOURS AND THEATRE TEMPERATURE WAS 18.1 DEGREES C.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178556 ↗