S-ROM 53-6318Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295172802), received between Jun 1, 2018 and Oct 28, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.

• MalfunctionOct 28, 2024Break; Crack; Material Deformation; Naturally Worn; Break; Crack; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL BROKE DURING HIP SURGERY. IT DID NOT BREAK INTO PIECES, IT DID NOT DELAY SURGERY, NOTHING WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20544752 ↗
• MalfunctionFeb 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PLANNED ON (B)(6) 2023. THE IMPRINT ON THE STEM BODY TRIAL WAS MISALIGNED. THIS EVENT WAS NOTICED ON (B)(6) 2023, BEFORE THE DEVICE WAS DELIVERED TO THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408481 ↗
• MalfunctionJan 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2022, THE S-ROM TRIAL STEM BODY18 IN QUESTION WAS OUT OF MIDLINE WHEN MATED WITH NECK TRIAL. THE DEVICE WAS ORDERED FOR THE SURGERY DATED (B)(6), 2022, IT WAS BEFORE USE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102492 ↗
• MalfunctionJun 1, 2018Bent; Scratched Material; Bent; Scratched Material

  NEW REP AT (B)(6) MEDICAL CENTER. WENT THROUGH INSTRUMENT INVENTORY ON (B)(6) 2018, AND NOTICED A FEW INSTRUMENTS THAT WERE IN AN UNACCEPTABLE CONDITION. THIS INSTRUMENT WAS NOT USED DURING A SURGERY AND NO STAFF MEMBER HAD MENTIONED THE DAMAGE. THIS IS A SROM 18 PROXIMAL BODY (COLOR: GREEN). THE GROOVES WHERE THE NECK TRIAL SITS ARE DAMAGED (BENT, CHIPPED). ASKING THAT THESE ARE REPLACED AND SHIPPED TO: (B)(6). THE DAMAGED INSTRUMENT WILL BE RETURNED TO (B)(4). LOT CODE: AH0604. ON THE COMPLAINT TOOL; YOU ARE UNABLE TO ADD THE LOT CODE. THE PRODUCT WON'T ADD/UPLOAD WHEN THE LOT IS ALSO TYPED. PATIENT CONSEQUENCE? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560361 ↗