NA 86-7444Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295217992), received between Sep 15, 2017 and Oct 7, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THE INITIAL PROCEDURE ON THE (B)(6) 2022 (RECEIVED AN S-ROM NOILES ROTATING HINGE KNEE). THE PATIENT FELT HIS KNEE "GIVE WAY", FOLLOWED BY SIGNIFICANT PAIN. UPON INVESTIGATION IT WAS DISCOVERED THAT THE "BOSS" FOR THE SLEEVE ATTACHMENT ON THE FEMORAL COMPONENT HAD BROKEN RESULTING IN FAILURE OF THE CONSTRUCT. THE PATIENT UNDERWENT REVISION SURGERY AND THE DAMAGED FEMORAL COMPONENTS WERE REMOVED AND REVISED TO AN LPS DISTAL FEMORAL REPLACEMENT. THE RETRIEVED IMPLANTS WERE SENT TO THE BIO-ENGINEERING DEPARTMENT AT ROYAL PERTH HOSPITAL AS PER STANDARD PROTOCOL HERE IN WA. IF OTHER, DESCRIBE --> N/A, IF OTHER, DESCRIBE --> REVISION KNEE SURGERY., PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> PAIN, INFLAMMATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> YES, IF YES, DESCRIBE --> X-RAYS, REVISION SURGERY, OTHER INFORMATION --> N/A, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-(B)(6). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-(B)(6). DEVICE PROPE

  Patient problems: Fall; Inflammation; Joint Laxity; Pain

  MAUDE report 15568441 ↗
• InjuryApr 12, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14084472 ↗
• InjurySep 10, 2021Fracture; Fracture

  (B)(4). THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. PATIENT HAD A LEFT DISTAL FEMORAL REPLACEMENT ON (B)(6) 2019 AFTER HISTORY OF FAILED HARDWARE PLATE AND SCREWS OF THE FEMUR. IT WAS REVISED FOR LOOSE SLEEVE COMPONENT AND FRACTURE OF THE STEM SLEEVE JUNCTION. THE STEM WAS WELL FIXED WITH FRACTURE AT THE THREADED PORTION OF THE STEM, LEAVING BEHIND THE THREADS OF THE STEM IN THE SLEEVE. THE SLEEVE AND FEMORAL CONSTRUCT WERE LOOSE AND REMOVED AS WELL WAS THE POLY. THE TIBIA WAS RETAINED AS WELL AS THE PATELLA COMPONENT OF THE LEFT KNEE. NO DELAY IN SURGERY. DOI:(B)(6) 2019. DOR:(B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12454022 ↗
• InjuryJul 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW THAT HOLDS THE STEM AND FEMORAL SLEEVE TOGETHER BROKE DUE TO LACK OF GOOD BONE SURROUNDING INTERFACE. THE SURGEON STATED THAT THE PATIENT DID NOT ACHIEVE BONE GROWTH INTO THE SLEEVE CAUSING SUPERIOR MIGRATION OF THE SLEEVE. THE SURGEON CEMENTED AN LPS STEM IN THE REVISED CONSTRUCT. DOI: (B)(6) 2017; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8840890 ↗
• InjuryJul 2, 2019Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PRESSFIT SLEEVE COMPONENT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE THREADS ON THE UNIVERSAL STEM BROKE OFF INSIDE THE FEMORAL SLEEVE. THE PRESSFIT SLEEVE CAME OUT EASILY AND THEY USED A TREPHINE TO REMOVE THE BROKEN STEM. DOI: (B)(6) 2018; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8754312 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FEMUR FRACTURE.

  Patient problems: No Code Available

  MAUDE report 8064373 ↗
• InjurySep 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6868533 ↗