S-ROM NOILES 62-3421RRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295179511), received between Nov 8, 2017 and Feb 27, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS HINGE KNEE REVISION DONE ON (B)(6) 2021. THE FEMUR BECAME LOOSE AND BROUGHT IN FOR REVISION. PREVIOUS TIBIAL COMPONENTS WERE RETAINED. A NEW HINGE FEMUR, FEMORAL CONE, CEMENTED STEM AND NEW HINGE INSERT WERE IMPLANTED. FEMUR, SLEEVE AND STEM WERE LOOSE. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23453700 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION ¿ PAIN/STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 22653045 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PATELLA REVISION ON (B)(6) 24, AND A DER WAS SUBMITTED, 969 IN OPTIMIZE. UNFORTUNATELY, DUE TO SHEER SIZE OF HER LEG, THE PATIENT DEVELOPED A HEMATOMA POSTOPERATIVELY. PATIENT WAS BROUGHT TO THE OR FOR AN EXTENSIVE I&D AND EVACUATION OF HEMATOMA. THE SURGEON EXCHANGED THE INSERT AND PIN FROM THE LISTED SROM FEMUR AND PLACED RESORBABLE ANTIBIOTIC BEADS. CULTURES WERE TAKEN BUT RESULTS WILL NO BE AVAILABLE FOR A NUMBER OF DAYS. THERE WAS NO DELAY OR PATIENT HARM. THERE ARE NO ALLEGATIONS AGAINST ANY DEPUY PRODUCTS, SIMPLY EXCHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 20191160 ↗
• InjuryJul 18, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINT PAIN AND LACK OF MOTION. SURGEON WENT IN AND FOUND THE COMPONENTS WELL FIXED. HE REMOVED THE INSERT AND PERFORMED AN I&D. SURGEON FELT THE FEM COMPONENT WAS PLACED IN TOO MUCH FLEXION. THE COMPONENT WAS REMOVED AND A NEW FEMORAL COMPONENT AND INSERT WAS INSERTED. THE TIBIAL COMPONENT WAS RETAINED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 19773041 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PROGRESSIVE PAIN AND RECURRENT HEMARTHROSIS RIGHT KNEE. BONE SCAN IMPLIED COMPONENTS MAY BE LOOSE. THEY WERE NOT. DOI: (B)(6) 2019 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19221249 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Pain

  MAUDE report 18856582 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. THE POLY WAS COMPLETELY REMOVED. THE FEMUR WAS LEFT IN BUT THE PIN (THAT¿S INCLUDED IN THE FEMUR PACKAGING) WAS REMOVED/REPLACED. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17722232 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL AND FRACTURED HIS DISTAL FEMUR BETWEEN HIS HINGED KNEE REPLACEMENT AND HIS PROXIMAL FEMORAL REPLACEMENT. WITH LITTLE BONE TO GAIN FIXATION BETWEEN THE IMPLANTS, THE SURGEON CHOSE TO CONVERT TO A TOTAL FEMUR. THE SURGERY WAS UNEVENTFUL AND NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16484885 ↗
• InjuryApr 27, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DELIVERY OF ALL THE INSTRUMENTATION AND IMPLANTS, EXCEPT THE NOILES FEMUR IMPLANTS. NO POSSIBILITY TO TROUBLESHOOT AROUND THE CLINIC BECAUSE THE ONLY DEPOT IS IN OTHER CITY ((B)(6)). SURGERY INITIATED AT 2PM AND COMPLETED AT 6PM. THE SURGEON MADE THE DECISION TO PERFORM THE SURGERY, PERFORMED THE BONE CUTS AND TESTS, THEN PUT A SPACER IN PLACE FOR RE-OPERATION ON (B)(6) 2022 WITH THE REMOVAL OF THE SPACER AND THE INSTALLATION OF THE FINAL IMPLANTS. THE IMPLANTS WERE CHECKED ONLY AT THE TIME OF THE INTERVENTION BY THE J&J TECHNICAL ADVISOR, WHO WARNED THE SURGEON AS SOON AS SHE HAD DISCOVERED IT. THE IMPLANT KITS COULD NOT HAVE BEEN SHOWN AS MISSING ON THE DELIVERY FORM AS IT WAS NOT RESERVED. SEVERAL ELEMENTS INVOLVED, INCLUDING THE LACK OF STAFF OF THE TEAM READY TO SUSTAIN QUALITY WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218078 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. THERE WAS ALSO LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13757184 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A KNEE REVISION WITH RETENTION OF FEMORAL SLEEVE AND STEM WITH SROM HINGE PLACEMENT. AT THAT TIME, AN MBT REVISION TRAY WAS PLACED INTO A 29 SLEEVE WITH CEMENTED STEM. ON (B)(6) 2020, THE PATIENT HAD COMPLETE EXPLANT OF FEMUR AND TIBIAL COMPONENTS. PHYSICIAN STATES, THE PATIENT HAS "NEVER DONE WELL." INFORMATION REGARDING THE OTHER IMPLANTS NOT LISTED ARE NOT KNOWN TO THE REP. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10713304 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A KNEE REPLACEMENT ON THE (B)(6) 2019. PATIENT WAS ADMITTED TO HOSPITAL DUE TO AN INFLAMMATION IN THE KNEE. REVISION SURGERY PLANNED FOR THE (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 10048011 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019, (B)(6) 2019, (INSERT ONLY). DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9749851 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED QUAD MECHANISM. SURGEON CHOSE TO REMOVE EXISTING COMPONENTS IN ORDER TO BE ABLE TO GET THE PATELLA TO AN APPROPRIATE LEVEL. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8754653 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8641233 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HINGE PIN AND POLY WAS REMOVED, WOUND WAS WASHED OUT AND SAME PARTS WERE PUT BACK IN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8033012 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 7932213 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNK DOR: (B)(6) 2018 UNK KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7894319 ↗
• InjuryAug 27, 2018Fitting Problem; Fitting Problem

  THE PATIENT WAS REVISED TO ADDRESS POOR RANGE OF MOTION AND PAIN ASSOCIATED WITH SIZE OF SROM HINGE FEMORAL COMPONENT. REVISED TO LPS XXSM DISTAL FEMUR. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Not Applicable; Pain

  MAUDE report 7819273 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4) DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ABOVE THE KNEE AMPUTATION RELATED TO WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOE: (B)(6) 2011; DOI: (B)(6) 2011; DATE OF AMPUTATION: (B)(6) 2011; (RIGHT, KNEE).

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7780921 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION RELATED TO PAIN, STIFFNESS, PAINFUL HINGE WITH NICKEL ALLERGY. DOI: (B)(6) 2015; DOR: (B)(4) 2018; (RIGHT, KNEE).

  Patient problems: Hypersensitivity/Allergic reaction; Not Applicable; Pain

  MAUDE report 7776425 ↗
• InjuryNov 8, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS COMPONENT LOOSENING AT UNKNOWN INTERFACE. ALSO, THE IMPLANTS WERE REMOVED AND REPLACED WITH THE LPS DISTAL FEMORAL REPLACEMENT.

  Patient problems: Inadequate Osseointegration; No Information

  MAUDE report 7009003 ↗