S-ROM 53-0302Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 10603295171539), received between Sep 12, 2017 and Sep 10, 2026 — classified as 185 malfunctions.

The most frequently reported specific device problem is “Break” (95 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721628 ↗
• MalfunctionJul 27, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034859 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT SROM HUDSON ADAPTER TIP SNAPPED WHILE REAMING DIAPHYSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888336 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT THE ADAPTER WAS BROKE DURING ACETABULAR REAMING DUE TO HARD BONE. THERE WAS NOTHING LEFT IN THE PATIENT AND NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859613 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE IT WAS OBSERVED THAT THE ADAPTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384527 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE ADAPTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384499 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE ADAPTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384444 ↗
• MalfunctionDec 19, 2025Break; Break

  INSTRUMENT BROKE DURING HIP SURGERY. THERE WERE NO DELAYS, NOTHING WAS LEFT INSIDE THE PATIENT, IT IS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851703 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS USING THE REAMER ADAPTER WHEN NOTICED THE TOP METAL OF THE ADAPTER WAS BREAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896419 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. WHILE REAMING THE RIGHT ACETABULUM, A PIECE OF A REAMER WAS BROKEN OUTSIDE OF THE PATIENT. BOTH BROKEN PIECES OF REAMER WERE FOUND ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479017 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT WAS BENT NOT BROKEN WHILE REAMING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331060 ↗
• MalfunctionJun 24, 2025Break

  WHILE REAMING THE RIGHT ACETABULUM, A PIECE OF A REAMER WAS BROKEN OUTSIDE OF THE PATIENT. BOTH BROKEN PIECES OF REAMER WERE FOUND ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317796 ↗
• MalfunctionJan 13, 2025Crack; Crack

  IT WAS REPORTED THAT DURING CLEANING IT WAS NOTICED THAT THE ADAPTOR HAS DEVELOPED A CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139329 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024 THAT ADAPTER TABS BROKE OFF. ALL PIECES WERE RETRIEVED AND THIS EVENT DID NOT CAUSE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747830 ↗
• MalfunctionNov 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGICAL TECH NOTED THE TIP WAS BROKEN AFTER A TOTAL HIP REPLACEMENT PROCEDURE. THE CAPTURE PRONGS WERE BENT OUT AND NO LONGER SECURED THE ATTACHED INSTRUMENT. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES AFFECTING PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694836 ↗
• MalfunctionOct 21, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

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

  MAUDE report 20492371 ↗
• MalfunctionSep 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WOULD NOT STAY CONNECTED TO THE REAMER. SURGICAL DELAY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20327167 ↗
• MalfunctionSep 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEON WAS USING THE ADAPTER AND IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237728 ↗
• MalfunctionSep 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THERE WAS NO DELAY. B. WHICH PART OF THE INSTRUMENT BROKE? THE TOP PART OF THE ADAPTOR BROKE. C. DID IT BREAK INTO 2 OR MORE PIECES? IT BROKE INTO 3 PIECES. D. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? THERE WAS NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237603 ↗
• MalfunctionAug 29, 2024Mechanical Jam; Mechanical Jam

  THE LOCKING MECHANISM OF THE INSTRUMENT IS NOT WORKING. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED, DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE, THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20101593 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED, THAT THE ADAPTOR BROKE UNDER HAND PRESSURE. NO HARM TO THE PATIENT OR EXTENDED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026723 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT THE SROM ANTIWOBBLE TINES BROKE OFF WHILE TEAMING.

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

  MAUDE report 19720136 ↗
• MalfunctionJun 26, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE OF CHECKING INSTRUMENT TRAYS IN OFFICE SETTING, THE END PIECES OF THE HUDSON ADAPTOR BROKE OFF AND WILL NO LONGER CONNECT TO ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613433 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT THE REAMER AND ADAPTER BOTH DAMAGED WHILE REAMING FEMUR. ALL PIECES REMOVED AND CASE PROCEEDED WITHOUT DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19370420 ↗
• MalfunctionApr 30, 2024Crack; Crack

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO PATIENT DELAY AND NO PATIENT CONSEQUENCE.

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

  MAUDE report 19212020 ↗