S-ROM NOILESRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 11 models of S-ROM NOILES by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2017 and Sep 13, 2024 — classified as 11 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported S-ROM NOILES problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Break5
- Device-Device Incompatibility4
- Fracture4
- Naturally Worn3
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Code Available5
- No Consequences Or Impact To Patient5
- Unspecified Infection3
- Bone Fracture(s)2
- Foreign Body Reaction2
- Joint Dislocation2
- Not Applicable2
S-ROM NOILES models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- S-ROM NOILES 63-3806AORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- S-ROM NOILES 62-1601PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- S-ROM NOILES 62-2176PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- S-ROM NOILES 62-1602PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- S-ROM NOILES 62-1604PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- S-ROM NOILES 62-1613PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- S-ROM NOILES 62-1621PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- S-ROM NOILES 62-1623PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- S-ROM NOILES 62-7115PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- S-ROM NOILES 62-7135PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- S-ROM NOILES 63-4170ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent S-ROM NOILES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. SROM KNEE CUT GUIDE HANDLES - BAD THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20214467 ↗MalfunctionDec 21, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT THE DEVICE WAS BROKEN INTO 2 PIECES. THERE WAS NO DELAYS IN SURGERY. AND NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18379796 ↗InjuryApr 14, 2023Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL POST OF THE POLY THAT ENABLES A ROTATING PLATFORM HAD SNAPPED OFF. THE POLY WAS IN TWO PIECES. THIS REQUIRED A REVISION SURGERY TO REPLACE THE POLY. NO DELAY REPORTED.
Patient problems: Insufficient Information
MAUDE report 16746465 ↗MalfunctionMar 29, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE IMPACTOR SLIDE IS STUCK. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16636252 ↗MalfunctionFeb 8, 2023Break; Break
IT WAS REPORTED THAT WHEN IMPACTING THE LPS FEMORAL COMPONENT FOR FINAL IMPLANTATION, THE CONNECTION BETWEEN THE LPS UNIVERSAL HANDLE BROKE AND THE IMPACTOR HEAD SEPARATED FROM THE IMPACTOR HANDLE. IT WAS NOTED THE FAILURE OCCURRED AT THE UNIVERSAL HANDLE CONNECTION SIDE OF THE INTERFACE. THE SURGEON USED JUST FEMORAL DRIVER PORTION TO FINALIZE IMPLANTATION OF THE IMPLANT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16327961 ↗MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility
THIS PC CAPTURES THE S-ROM FEMORAL DRIVER THAT WOULD NOT CONNECT TO THE SROM UNIVERSAL HANDLE QUICK RELEASE. IT WAS REPORTED THAT THERE WAS A LEFT-SIDED PERIPROSTHETIC NONUNION FRACTURE PROXIMAL TO THE CONSTRAINED TKA. ALSO, THE S-ROM FEMORAL DRIVER WOULD NOT CONNECT TO THE SROM UNIVERSAL HANDLE QUICK RELEASE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12924974 ↗MalfunctionOct 8, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTOR HANDLE WILL NOT CONNECT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12598360 ↗MalfunctionAug 4, 2021Break; Break
IT WAS REPORTED THAT ONE OF THE POSTS USED TO PULL BACK THE SPRING LOADED ATTACHMENT ON THE BROACH HANDLE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274388 ↗MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEPUY OFFICE PERSONNEL CALLED TO MAKE AWARE, IMPACTOR WILL NOT RELEASE FROM THE HANDLE. THE INSTRUMENT WORKED FINE IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10690138 ↗MalfunctionAug 24, 2020Break; Break
REVISION KNEE REPLACEMENT; THE SURGEON WAS IMPACTING A DISTAL FEMUR WHEN THE IMPACTOR BROKE. ACTION TAKEN TO MANAGE THE ISSUE: USED A SECOND HANDLE THAT WAS AVAILABLE WITHIN THE SAME KIT. NO AE TO PATIENT. NO DELAY TO THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10444514 ↗MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO SURGICAL DELAY NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10396384 ↗InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE SURGEON EXPLANTED POLY AND RELEASED SOFT TISSUE. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.
Patient problems: No Code Available
MAUDE report 9621549 ↗MalfunctionJun 14, 2019Break; Break
IT WAS REPORTED THAT THE HANDLE WAS BROKEN, ALL PIECES WERE FOUND. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8699996 ↗InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON PERFORMED AN I&D WITH LINER CHANGE FOR INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8500182 ↗InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS OPENED, BEARING REMOVED, WASHOUT AND DEBRIDEMENT OF AREA AND THE POLY AFTER SOAKED IN CHLORHEXIDINE WAS PUT BACK IN.
Patient problems: Unspecified Infection
MAUDE report 8455203 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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