S-ROM 2576-16-105Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 16 B LARGE · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295146438), received between Jul 21, 2017 and Mar 24, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (6 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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn6
- Illegible Information5
- Scratched Material5
- Material Twisted/Bent3
- Device Markings/Labelling Problem2
- Device-Device Incompatibility2
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient8
- No Information1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
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 24681190 ↗MalfunctionAug 6, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). THE BOTTOM OF THE TRIAL WAS WARPED AND WOULD NOT EXTRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22729769 ↗MalfunctionJun 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE BOTTOM OF THE TRIAL IS DINGED UP TO THE POINT WHERE THE EXTRACTOR DOES NOT REMOVE IT ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22286151 ↗MalfunctionJun 29, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT SLEEVE TRIALS ARE DAMAGED AND NO LONGER FIT ON ¿SLEEVE INTRODUCER¿. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224312 ↗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 15104770 ↗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 14675322 ↗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 14674950 ↗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 14674566 ↗MalfunctionApr 27, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THESE INSTRUMENTS HAVE EXCESSIVE WEAR AND ARE DIFFICULT TO READ. REP INDICATED "THAT THEY NEED TO BE REPLACED". NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10002000 ↗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 9912530 ↗MalfunctionAug 6, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT THE SLEEVE GOUGED WAS BENT. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8864444 ↗MalfunctionApr 3, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
CSSD ALSO REPORTED SOME CHIPPING AND BENT PORTIONS OF THE SROM TRIAL SLEEVES. IF OTHER, DESCRIBE CSSD STAFF REPORTED NOTICING AFTER STERILIZING INSTRUMENTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8479787 ↗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 8466290 ↗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 8466272 ↗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 7995549 ↗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 7439498 ↗MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE NECK SLEEVE HAS A DEEP GOUGE JUST UNDERNEATH THE TOP END OF THE INSTRUMENT AND THE TOP SURFACE IS SCARRED AS WELL.
Patient problems: No Information
MAUDE report 6731801 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page