S-ROM 2576-36-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295147053), received between Sep 14, 2017 and Dec 9, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Material Integrity Problem; Material Integrity Problem

  THE PRODUCT DAMAGE 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. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757039 ↗
• MalfunctionOct 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2025. THE 36 NEUT NECK WOULD NOT TIGHTEN ONTO THE SROM STEM TO TRIAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341569 ↗
• MalfunctionFeb 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENTS WOULD NOT TIGHTEN TOGETHER FOR TRIALING FROM THE SROM HIP INSTRUMENT HIT WHICH MADE THE CASE VERY DIFFICULT FOR SURGEON AND ADDED TIME. THE NECK TRIAL WOULDN'T TIGHTEN TO THE STEM TRIAL, AND THE SURGEON HAD GREAT DIFFICULTY IN TRIALING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 21459618 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT NECK TRIAL WOULD NOT SCREW ON TO THE TRIAL STEM. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064831 ↗
• MalfunctionApr 13, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE SURGERY WAS TAKING PLACE, THE PRODUCTS LISTED BELOW WERE ALL TRIALED AND SHOWED SIGNS OF DYSFUNCTION. NEITHER THE BODIES OR THE STEMS WOULD FULLY LOCKED DOWN AND CONNECT TO EACH OTHER. SOME OF THE BODY SHOWED SIGNS OF THREADED THREADS. SURGERY WAS DELAYED. THERE WERE NO PARTS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657128 ↗
• MalfunctionApr 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECKS NO LONGER STAY LOCKED DOWN ON THE STEM TRIALS. THE NECK WILL SPIN ON THE STEM TRIAL ONCE THE NECK IS TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653191 ↗
• MalfunctionApr 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECKS NO LONGER STAY LOCKED DOWN ON THE STEM TRIALS. THE NECK WILL SPIN ON THE STEM TRIAL ONCE THE NECK IS TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653178 ↗
• MalfunctionFeb 19, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information; Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729008 ↗
• MalfunctionJul 31, 2019Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE THREAD ON THE TRIAL SROM NECK WAS STRIPPED AND THEY WON'T TIGHTEN TO THE STEM TRIAL. THE HEAD BALL TRIAL 28+3MM HAS SCRATCHED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846938 ↗
• MalfunctionFeb 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SROM NECK TRL 36 STD THREADS MESSED UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347335 ↗
• MalfunctionDec 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  SROM NECK TRIAL WOULD NOT FULLY LOCK ONTO STEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162106 ↗
• MalfunctionSep 17, 2018Break; Break

  AT TRAILING PHASE, SURGEON WENT TO USE TRAIL AS PREPARED FOR. THIS WAS THE 16X11 TRIAL, WITH A 36 STANDARD NECK. THESE TWO ARE JOINED WITH A SCREW AND THREAD, AND INTERLOCK WITH TEETH ON BOTH COMPONENTS. TO CHANGE THE VERSION, THE NECK CAN BE ROTATED, AND THEN LOCKED ONTO THE STEM. HOWEVER THIS LOCKING MECHANISM WAS BROKEN, CAUSING SIGNIFICANT PROBLEMS AND DELAY TO SURGERY AS HE COULD NOT TRAIL THE STEM VERSION. TO COMPLETE THE PROCEDURE, THE SURGEON HAD TO OPEN THE DEFINITIVE IMPLANT AND APPROXIMATE IDEAL VERSION OF THE STEM. SURGEON INDICATED THIS IS NOT THE FIRST TIME IT HAS HAPPENED. A 30 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7880368 ↗
• MalfunctionApr 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPACTOR HANDLE CRACKED AFTER YEARS OF USE. THE TWO NECK TRIALS ALSO STRIPPED AND IT WILL NOT STAY ON THE STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439427 ↗
• MalfunctionJan 23, 2018Break; Break

  IT WAS REPORTED THAT THE THREADS ON TRIAL NECK ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7212019 ↗
• MalfunctionDec 12, 2017Device Issue; Device Issue

  IT WAS REPORTED THAT THE 36 STANDARD NECK TRIAL WILL NO LONGER TIGHTEN TO TRIAL STEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7111288 ↗
• MalfunctionSep 14, 2017Misconnection; Misconnection

  IT WAS REPORTED THAT THE STEM BODY TRIAL STRIPPED AND WON'T CONNECT TO THE NECK TRIALS AND NEED TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 6864288 ↗