S-ROM 2576-16-100Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 16 B SMALL · Class 1
Quick summary
This DePuy S-ROM trial sleeve is a size-checking instrument surgeons use to size hip implants before the actual implant goes in. The 30 reports mostly describe wear and tear: scratched and worn surfaces, size markings rubbed off so they can't be read, and sleeves so damaged at the end that the extractor tool can't grip them and the trial won't come out. There are no deaths, 1 injury, and 29 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295146421), received between Jul 21, 2017 and Apr 17, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (9 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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn9
- Illegible Information8
- Scratched Material8
- Appropriate Device Problem Term/Code Not Available4
- Device-Device Incompatibility4
- Material Deformation4
- Material Twisted/Bent3
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient12
- No Information4
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THESE INSTRUMENTS HAVE REACHED END OF LIFE. THE SURGEONS HAVE CONTINUALLY COMPLAINED ABOUT WEAR AND TEAR OF INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24909782 ↗MalfunctionMar 24, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675171 ↗MalfunctionMar 5, 2026Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE SROM TRIALS ARE TOO SCRATCHED, AND DIFFICULT TO READ THE SIZES. ALSO, THE OFFSET REAMER HANDLE STOPPED WORKING. FINISHED WITH A DIFFERENT REAMER. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521971 ↗MalfunctionFeb 18, 2026No Apparent Adverse Event
IT WAS REPORTED A DEVICE WAS RECEIVED FOR ANALYSIS AS A BLIND UNIT. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379722 ↗MalfunctionDec 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOTTOM IS WARPED SO THE TRIAL WILL NOT EXTRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791483 ↗MalfunctionJul 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS DISCOVERED THAT THE TRIAL WOULD NOT EXTRACT BECAUSE IT WAS WORN ON THE BOTTOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22545648 ↗MalfunctionJun 6, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE BOTTOM OF THE TRIAL WAS NICKED UP TO THE POINT WHERE IT CANNOT BE EXTRACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22158513 ↗MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOTTOM OF THE INSTRUMENT WAS BEAT UP SO BAD THAT THE SLEEVE EXTRACTOR WILL NOT GRAB HOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116947 ↗MalfunctionJul 26, 2022No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE NOT EASILY EXTRACTED FROM FEMUR FOR REPEATED USE AND WEAR. SURGEON HAS REQUESTED THEY BE REPLACED. LOT NUMBERS NOT AVAILABLE DUE TO WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15104848 ↗MalfunctionJun 13, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE NOT EASILY EXTRACTED FROM FEMUR FOR REPEATED USE AND WEAR. SURGEON HAS REQUESTED THEY BE REPLACED. LOT NUMBERS NOT AVAILABLE DUE TO WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14675273 ↗MalfunctionJun 13, 2022Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE GETTING STUCK IN THE FEMUR AND NOT EASILY EXTRACTED DUE TO REPEATED USE. SURGEON REQUESTED THEY BE REPLACED. LOT NUMBERS ARE NOT LEGIBLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674973 ↗MalfunctionJun 13, 2022Break; Naturally Worn; Illegible Information; Break; Naturally Worn; Illegible Information
IT WAS REPORTED THAT TRIAL SLEEVE IS DIFFICULT TO EXTRACT DUE TO REPEATED USE. MATERIAL HAS BEEN CHIPPED AND PRODUCT ETCHINGS ARE ILLEGIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674549 ↗MalfunctionFeb 16, 2021Material Integrity Problem; Illegible Information; Material Integrity Problem; Illegible Information
IT WAS REPORTED THAT THE SLEEVE TRIAL IS DAMAGED AND NO LONGER EXTRACTED FROM FEMUR EASILY. LOT NUMBER IS UNAVAILABLE BECAUSE IT IS NOT LEGIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11334118 ↗MalfunctionApr 1, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED AND ARE DAMAGED. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9912535 ↗MalfunctionApr 1, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED OR DAMAGED. NOT USED IN A CASE. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9912532 ↗MalfunctionFeb 27, 2020Material Twisted/Bent; Scratched Material; Illegible Information; Material Twisted/Bent; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE DIFFICULT TO IMPOSSIBLE TO READ SIZING DUE TO WEAR AND TEAR AND NORMAL EVERYDAY USE. THE NEED TO BE REPLACED SO THAT THE SURGEON IS ABLE TO SAFELY DETERMINE THE SIZE OF THE TRIAL BEING USED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9765937 ↗MalfunctionDec 11, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE SLEEVE TRIALS ALONG THE DISTAL EDGE HAD BEEN WORN AND BENT WHERE THEY CANNOT BE EXTRACTED AND GETTING STUCK IN THE FEMUR. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9450500 ↗MalfunctionOct 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9239790 ↗MalfunctionOct 23, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226280 ↗MalfunctionAug 8, 2019Break; Display Difficult to Read; Naturally Worn; Break; Display Difficult to Read; Naturally Worn
DAMAGED SLEEVE - MISSING SIZE ENGRAVING. IF OTHER, DESCRIBE: NO SERIAL NUMBER AVAILABLE. ONLY PRODUCT NUMBER AVAILABLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8875344 ↗MalfunctionMar 29, 2019Device Markings/Labelling Problem; Naturally Worn; Scratched Material; Device Markings/Labelling Problem; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN OUT AND CANNOT READ ETCHING. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466281 ↗MalfunctionMar 29, 2019Device Markings/Labelling Problem; Naturally Worn; Scratched Material; Device Markings/Labelling Problem; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN OUT AND CANNOT READ ETCHING. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466226 ↗MalfunctionFeb 22, 2019Stretched; Material Twisted/Bent; Scratched Material; Stretched; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT THE SLEEVE TRIAL WAS STRETCHED OUT AND WILL NOT FIT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8361265 ↗MalfunctionOct 23, 2018Naturally Worn; Naturally Worn
LARGE SLEEVE TRIALS WERE DAMAGED FROM CONTINUED USE AND WOULD NOT DISENGAGE FROM THE SLEEVE INSERTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7995534 ↗MalfunctionApr 18, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SROM SLEEVES HAVE BECOME WORN FROM SAWING AND NEED REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7439508 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.