S-ROM NOILESRecalls & reported problems across all models
Depuy (Ireland) · 25 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 208
- Deaths reported
- 0
- Injuries reported
- 167
- Recalls
- 0
We found 25 models of S-ROM NOILES by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 208 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2017 and Jun 29, 2026 — classified as 167 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (17 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 Problem116
- Break17
- Loss of or Failure to Bond17
- Insufficient Device Problem Information11
- Fracture8
- Naturally Worn8
- Device Dislodged or Dislocated7
- Device-Device Incompatibility7
Patient problems
- Unspecified Infection68
- No Code Available41
- Pain41
- No Clinical Signs, Symptoms or Conditions27
- Joint Laxity18
- Insufficient Information17
- No Consequences Or Impact To Patient11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
S-ROM NOILES models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- S-ROM NOILES 62-1640PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER51 reports
- S-ROM NOILES 62-3401RPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER23 reports
- S-ROM NOILES 62-3421LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- S-ROM NOILES 62-3421RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- S-ROM NOILES 62-3411LPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- S-ROM NOILES 62-3401LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- S-ROM NOILES 62-3411RPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- S-ROM NOILES 63-3805AIMPACTOR9 reports
- S-ROM NOILES 2163-11-001TEMPLATE7 reports
- S-ROM NOILES 63-3305ATEMPLATE6 reports
- S-ROM NOILES 62-1641PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- S-ROM NOILES 63-3810CLAMP4 reports
- S-ROM NOILES 62-3810PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- S-ROM NOILES 63-3802DRIVER, PROSTHESIS3 reports
- S-ROM NOILES 2178-01-105TRAY, SURGICAL, INSTRUMENT2 reports
- S-ROM NOILES 62-1642PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- S-ROM NOILES 62-3684PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- S-ROM NOILES 62-3685PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- S-ROM NOILES 62-3805PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- S-ROM NOILES 63-2801AEXTRACTOR2 reports
- S-ROM NOILES 63-3306ATEMPLATE2 reports
- S-ROM NOILES 2163-11-004TEMPLATE1 report
- S-ROM NOILES 62-1635PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- S-ROM NOILES 63-4133TEMPLATE1 report
- S-ROM NOILES 63-4232TEMPLATE1 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.
InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS INFECTED WITH MRSA. PIN AND INSERT WERE REMOVED. WASHED OUT. NEW INSERT AND REPLACEMENT PIN IMPLANTED. DOI: (B)(6), 2024 DOR: (B)(6), 2026 AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25655252 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE KNEE WAS INFECTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25461496 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A PREVIOUS LEFT DFR REPLACEMENT. PATIENT HAD ALSO HAD A PREVIOUS I&D DONE TWO YEARS AGO. SHOWING SIGNS OF INFECTION AND BROUGHT IN FOR I&D WITH INSERT EXCHANGE. NO COMPLAINTS OR DELAYS IN SURGERY. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25436037 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE. IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.
Patient problems: Joint Laxity; Pain
MAUDE report 24966528 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE.IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.
Patient problems: Joint Laxity; Pain
MAUDE report 24965904 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE. IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.
Patient problems: Joint Laxity; Pain
MAUDE report 24965802 ↗MalfunctionApr 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS OBSERVED THAT AN UNKNOWN PIN DEFORMED INSIDE THE S-ROM CUTTING BLOCK. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828661 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED. WASH OUT AND POLY SWAP WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24823072 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED A FALL POST TOTAL KNEE ARTHROPLASTY (TKA), RESULTING IN A TORN SURGICAL REPAIR AND DAMAGE TO THE QUADRICEPS MECHANISM. THE SURGEON DETERMINED THAT SHORTENING THE FEMORAL CONSTRUCT WOULD REDUCE TENSION ON THE REPAIR, LEADING TO REMOVAL OF THE FEMORAL COMPONENTS AND EXCHANGE OF THE PATELLAR COMPONENT TO A CEMENTED VERSION. ALL COMPONENTS WERE FUNCTIONING WELL PRIOR TO THE FALL, AND THERE WAS NO DELAY OR ADDITIONAL PATIENT HARM NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Fall; Unspecified Tissue Injury
MAUDE report 24474491 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component; No Apparent Adverse Event
ADDITIONAL INFORMATION STATES: CAN YOU PLEASE CLARIFY THE EXACT ALLEGATIONS AGAINST THE REPORTED PRODUCT? DID IT BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, DULL, WORN OR CROSS THREADED? MOST OF THEM HAVE JUST WEAR AND TEAR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321444 ↗InjuryJan 22, 2026Fracture
IT WAS REPORTED THAT SROM NRHFEM W/PIN SM RT 66X62 AND LPS UNIV TIB HIN INS SM 31MM WERE INVOLVED IN A REPORTED EVENT DURING A KNEE SURGERY. THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SUSPECTED FRACTURE OF THE HINGE FEMUR IMPLANT, SPECIFICALLY AT THE BOSS WHERE THE HINGED FEMUR ATTACHES TO THE FEMORAL SLEEVE AT THE MORSE TAPER LOCKING INTERFACE. A LARGE PORTION OF THE FRACTURED IMPLANT REMAINED LODGED IN THE UNIVERSAL FEMORAL SLEEVE, NECESSITATING REMOVAL OF BOTH THE SLEEVE AND STEM. ADDITIONALLY, A PACKAGING ISSUE WAS NOTED WITH THE LPS UNIV TIB HIN INS SM 31MM IMPLANT, AS ITS INNER PACKAGING WAS CRACKED; THE IMPLANT WAS USED BECAUSE NO ALTERNATIVE WAS AVAILABLE, AND THE PREVIOUSLY INTENDED IMPLANT WAS DROPPED. THE SROM NRHFEM W/PIN SM RT 66X62 WAS IMPLANTED, AND THE LPS UNIV TIB HIN INS SM 31MM WITH DAMAGED PACKAGING WAS ALSO IMPLANTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR INJURY RELATED TO THE PACKAGING EVENT, BUT THE IMPLANT FRACTURE REQUIRED CORRECTIVE INVASIVE SURGERY FOR DEVICE REVISION AND REPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 24146007 ↗InjuryJan 15, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE FEMUR FOLLOWING A REVISION TOTAL KNEE ARTHROPLASTY. X-RAYS REVEALED LUCENCY AROUND THE FEMORAL SLEEVE AND REMODELING IN THE FEMUR AROUND THE STEM, SUGGESTING LOOSE COMPONENTS. THE TIBIAL COMPONENTS APPEARED TO BE WELL FIXED AND SLEEVE APPEARED TO BE INGROWN. A FEMORAL SIDE REVISION WAS PERFORMED WITH NO DELAY AND NO PATIENT HARM. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.
Patient problems: Discomfort
MAUDE report 24082022 ↗InjuryJan 7, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE AND STABILITY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PREVIOUS TRAUMATIC INJURY. THE PREVIOUS IMPLANTS WERE UPSIZED BECAUSE OF LOOSENING IN THE TIBIA AND FEMUR AND THE ACTUAL POLYETHYLENE WAS NOT WORN OUT. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 23992711 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A DEHISCED KNEE FROM PREVIOUS SURGERY. PATIENT WAS WASHED OUT AND WOUND WAS REVISED. THE DOCTOR DECIDED TO REPLACE POLY DURING I&D OF THE JOINT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.
Patient problems: Wound Dehiscence
MAUDE report 23817557 ↗InjuryDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THE S-ROM FEMUR COMPONENT CEMENTED? - THERE WAS SIGNIFICANT BONE LOSS SO IT APPEARS THE SROM FEMUR WAS NOT ABLE TO BE CEMENTED. B. WAS THE SLEEVE IMPLANT WELL-FIXED? - THE SLEEVE WAS WELL FIXED. C. WAS THE FEMUR TO SLEEVE MORSE TAPER CONNECTION SOLID, OR HAD IT COME LOOSE/LOST ITS MORSE TAPER FIXATION? D. WHAT IS THE EXACT ALLEGATION AGAINST ATTUNE REV LPS INSRT XSM 20MM? - IT SEEMED ALL THE STRESS PLACED ON THE TAPER HAD CAUSED THE FEMUR TO LOOSEN FROM THE SLEEVE. E. PLEASE PROVIDE THE LOT NUMBER AND PRODUCT CODE FOR UNK KNEE FEMORAL SLEEVE. - NO ALLEGATION REGARDING THE INSERT, BUT IT WAS REMOVED AND REPLACED.
Patient problems: Bone Notching; Fluid Discharge; Foreign Body Reaction; Joint Laxity; Swelling/ Edema
MAUDE report 23749393 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →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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