S-ROM 2576-11-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295146063), received between Sep 14, 2017 and Apr 11, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE PRODUCTS HAD REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS COMPLAINED THAT INSTRUMENTS WERE DULL, ILLEGIBLE, AND GENERALLY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846149 ↗
• MalfunctionNov 17, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT REAMER SHAFT WOULD NOT FIT INTO THE REAMER ADAPTER, AND IT LOOKED BENT. IT WAS FURTHER OBSERVED THAT THE NECK TRIAL AND STEM TRIAL WOULD NOT SCREW TOGETHER AND SEEM TO BE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576007 ↗
• MalfunctionOct 22, 2025No Apparent Adverse Event; Illegible Information; No Apparent Adverse Event; Illegible Information

  IT WAS REPORTED THAT THE SROM TRIALS ARE TOO WORN AND DIFFICULT TO READ. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23362466 ↗
• 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 21459615 ↗
• MalfunctionSep 7, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT S-ROM DISTAL STEM TRIAL (11MM) IS GOUGED. DID THE EVENT OCCUR DURING FIELD INSPECTION? NO. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(6). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697592 ↗
• MalfunctionApr 19, 2023Corroded; Corroded

  DEVICES APPEAR RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767562 ↗
• MalfunctionJan 4, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE END WITH LOCKING GROOVES IS STRIPPED AND WILL NOT LOCK WITH NECK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151063 ↗
• MalfunctionAug 23, 2021Material Integrity Problem; Material Integrity Problem

  INSTRUMENTS DAMAGED FROM PREVIOUS SROM CASES. FOUND TO BE DAMAGED AT THE CASE. X2 DAMAGED SLEEVE TRIALS NEED REPLACING -DAMAGED. X1 11X16 STEM TRIAL NEEDS REPLACING -DAMAGED. X1 PLASTIC FRAME SLEEVE NEEDS REPLACING -IS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356541 ↗
• 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 11657073 ↗
• MalfunctionFeb 11, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS STRIPPED. THERE WAS NO SURGICAL DELAY AND NO PIECES WERE BROKEN OFF FROM THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313919 ↗
• MalfunctionFeb 20, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SIZES OF THE SROM INSTRUMENTS WERE DIFFICULT OR IMPOSSIBLE TO READ. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734654 ↗
• MalfunctionFeb 20, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENT 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 9732499 ↗
• 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 7880372 ↗
• MalfunctionOct 4, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE STERILE PROCESSING CALLED THE REP TO COME TO THEM AND SAID THEY COULD NOT GET THESE TWO INSTRUMENTS APART. THEY TRIED SOAKING THEM OVER THE WEEKEND BUT IT DID NOT WORK. ALSO TRIED TO PRY THEM OPEN, IT DID NOT WORK. DID NOT KNOW THEY WERE STUCK TOGETHER UNTIL TUESDAY (B)(6) AFTER THE LONG WEEKEND. IT WAS STATED THAT IT WAS NOT BROKEN BUT JAMMED TOGETHER.

  Patient problems: No Information

  MAUDE report 6914647 ↗
• 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 6864262 ↗