S-ROM 53-6450Recalls & reported problems
Depuy (Ireland) · S-ROM STEMSLEEVE SEPARATOR · Class 1
All models of S-ROM (185)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy S-ROM separator is an orthopedic manual surgical instrument used with hip stems. Reports mostly describe the tip bending, chipping, cracking or breaking off, often noticed during kit inspection without patient impact. There are 25 adverse event reports that name its identifier, with no deaths and no injuries. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295172901), received between Sep 26, 2017 and Jul 28, 2025 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (11 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation11
- Break7
- Material Integrity Problem4
- Material Twisted/Bent4
- Naturally Worn2
- Scratched Material2
- Crack1
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient8
- Insufficient Information2
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT SPD DID NOT ACCEPT THIS INSTRUMENT AS IT WAS TOO BADLY DAMAGED. THE TIP WAS BENT TO ONE SIDE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632302 ↗MalfunctionFeb 3, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem
IT WAS REPORTED THAT SOME INSTRUMENTS WERE CRACKED AND DAMAGED. NO IMPACT TO PATIENT; NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295203 ↗MalfunctionJan 29, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT BENT DURING USE. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. IT WAS UNKNOWN IF THEY PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263392 ↗MalfunctionDec 26, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2024 , THE HEAD DISTRACTION TIP WAS BENT DURING USE FOR HEAD REMOVAL. THERE WAS NO ADDITIONAL SURGERY TIME WAS REQUIRED. BACKUP INSTRUMENT WAS ON HAND.
Patient problems: Insufficient Information
MAUDE report 21021033 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON OCTOBER 9, 2024, THE TIP OF THE INSTRUMENT WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439982 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THAT THE SROM STEM SLEEVE SEPARATOR IMPACTOR IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20363650 ↗MalfunctionSep 13, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. S-ROM*STEM/SLEVE SEPARTOR - BENT TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20213146 ↗MalfunctionJan 16, 2024Break; Break
THIS INSTRUMENT IS COMPOSED OF 1 PART. THE INSTRUMENT HAS SNAPPED OFF. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18517200 ↗MalfunctionJan 5, 2024Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE END WAS BENT AND SNAPPED OFF. PATIENT STATUS/ OUTCOME / CONSEQUENCES: 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)(4). 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 18453450 ↗MalfunctionJun 27, 2023Break; Break
IT WAS REPORTED THAT THE STEM/SLEEVE SEPARATOR WAS CHIPPED OFF DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17210948 ↗MalfunctionMay 10, 2023Break; Material Deformation; Break; Material Deformation
IT REPORTED THAT IT WAS NOTICED THAT THESE INSTRUMENT WERE DAMAGED OR BEAT UP. INSTRUMENTS ARE CHIPPED OR BENT. NOTHING LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16902408 ↗MalfunctionSep 6, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIP IS BENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15364225 ↗MalfunctionNov 15, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE TIP IS DULL AND FLATTENED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814019 ↗MalfunctionAug 5, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT WHILE USING THE CHISEL TO BREAK THE TAPER, A DEFORMITY WAS CREATED IN THE FLAT TIP END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12280030 ↗MalfunctionJun 25, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED AS "DAMAGED TRYING TO GET STEM OUT DURING A REVISION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12066000 ↗MalfunctionJun 25, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED AS "DAMAGED TRYING TO GET STEM OUT DURING A REVISION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12065999 ↗MalfunctionMar 22, 2021Material Integrity Problem; Material Integrity Problem
STOM STEM SEPARATOR DAMAGED. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11541304 ↗MalfunctionOct 13, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE LPS EXTRACTOR ADAPTER WAS STUCK ON LPS INSERTER HANDLE. SROM OSTEOTOME IS WARPED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10671044 ↗MalfunctionApr 3, 2020Material Twisted/Bent; Scratched Material; Illegible Information; Material Twisted/Bent; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9919388 ↗MalfunctionOct 1, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TRIAL 15MM STEM AND THE 36+8 NECK SEGMENT ARE BOTH STRIPPED AND WOULD NOT ENGAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7923841 ↗MalfunctionAug 30, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE STEM/SLEEVE SEPARATOR BENT DURING USE. NO ADDITIONAL INFORMATION. PLEASE REPLACE TO OUR (B)(6) HOLD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7832503 ↗MalfunctionAug 23, 2018Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN OUT AND BENT AND NEEDS TO BE REPLACED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7809266 ↗MalfunctionAug 20, 2018Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE IMPACTION END IS DULL AND FLAT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7798891 ↗MalfunctionAug 20, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT IMPACTION IN IS BEND AND DULL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7796850 ↗MalfunctionSep 26, 2017Break; Break
COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE SET OF SROM HIP INSTRUMENTS WERE PUT TOGETHER AND NOTICED TIP OF SLEEVE EXTRACTOR WAS SEVERELY DAMAGED.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6894673 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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