LPS 1987-27-326Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295079637), received between Nov 18, 2022 and Mar 26, 2026 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026No Apparent Adverse Event

  REVISION KNEE CASE: PATIENT UNDERWENT REVISION OF A NOILES FEMUR WHICH APPEARED TO HAVE SNAPPED AT THE BASE OF THE FEMORAL COMPONENT AND THE SLEEVE. THE PROCEDURE WAS DONE NINE YEARS AGO, AND THIS IS THE THIRD TIME THIS PATIENT HAS BEEN REVISED.

  Patient problems: Insufficient Information

  MAUDE report 24699431 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  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 23992687 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR AN INFECTED LEFT HINGE KNEE. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED. THERE WERE NO SURGICAL DELAYS, DEFICIENCIES OR BROKEN INSTRUMENTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17135139 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT FALLING ON HIS KNEE. UPON EXPOSURE TO THE JOINT SPACE IT WAS DISCOVERED THAT MEDIUM SROM HINGED FEMUR HAD LOOSENED AWAY FROM THE POROUS FEMORAL SLEEVE CONSTRUCT. THE LOOSENING OCCURRED AT THE TAPER POINT OF THE FEMUR TO THE SLEEVE. SURGEON REMOVED THE STILL ENGAGED HINGED PIN WITH A PAIR OF KOCHERS AND THEN REMOVED THE MEDIUM X 26MM POLY WITH HIS HAND AND THEN REMOVED THE MEDIUM RIGHT FEMUR BY HAND. UPON FURTHER EXAMINATION THE SURGEON STATED THAT NONE OF THE IMPLANTS HAD BROKEN OR SHOWN UNUSUAL WEAR BUT HAD SIMPLY DISENGAGED AS A RESULT OF THE FALL THE PATIENT EXPERIENCE. THE TIBIAL COMPONENT AND FEMORAL SLEEVE/STEM WERE WELL FIXED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Pain; Unspecified Infection

  MAUDE report 15829240 ↗