SMARTSET 85-8874Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295215257), received between Jul 26, 2019 and Jun 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIZE ISSUE. IN A TOTAL HIP REPLACEMENT PROCEDURE(IT WAS REPORTED THAT THE PATIENT HAD FRACTURE, AND THE FRACTURE LOCATION WAS UNKNOWN), THE SURGEON FOUND THAT THE MATCHED SROM TRIAL HAD VERY DIFFERENT SIZES WITH THE SROM FEMORAL STEM. IT WAS FOUND THE TRIAL WAS IN THE SAFE AREA ABOVE THE FRACTURE LINE, WHILE THE PROSTHESIS WAS CLOSE TO THE FRACTURE LINE DURING IMPLANTATION. THEN THE SURGEON CHANGED ANOTHER BRAND OF FEMORAL STEM TO COMPLETE THE SURGERY, THE SURGERY TIME WAS EXTENDED FOR 40 MIN.

  Patient problems: Limb Fracture

  MAUDE report 19459880 ↗
• MalfunctionJul 26, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT MULTIPLE SROM REAMERS WERE DAMAGED DURING A SURGERY WITH SURGEON. THE REAMERS WERE USED TO "REAM" THROUGH SOME HARDWARE LEFT IN A HIP. SINCE THE REAMERS WERE USED TO DO THIS, MANY OF THEM HAVE BEEN DAMAGED AND NEED TO BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831126 ↗