LPS 1987-26-417Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295079323), received between Jul 21, 2017 and Mar 4, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Osseointegration Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIGMA TC3 KNEE REVISION PROCEDURE. AFTER A PREVIOUS REVISION, THE PATIENT WAS REVISED TO AN LPS DISTAL FEMUR ON (B)(6) 2025. THE PATIENT BEGAN EXPERIENCING PAIN AFTER INCREASED REHABILITATION ACTIVITY, AND IMAGING REVEALED MOVEMENT OF THE FEMORAL COMPONENT. THE ENTIRE DISTAL FEMUR WAS REMOVED DUE TO LOOSENING AND REVISED WITH A CEMENTED STEM, WHILE THE TIBIAL COMPONENT REMAINED WELL FIXED AND WAS NOT REVISED. THE REVISION WAS ATTRIBUTED TO LOOSENING OF THE STEM AT THE BONE-TO-IMPLANT INTERFACE, SPECIFICALLY AT THE POROUS FEMORAL STEM. DOI- (B)(6) 2025; DOR- (B)(6) 2026; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24507956 ↗
• InjuryFeb 14, 2020Use of Device Problem; Loss of Osseointegration; Malposition of Device; Use of Device Problem; Loss of Osseointegration; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PRESSFIT STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE CONSTRUCT WAS ROTATED. REPLACED WITH A CEMENTED STEM AND INSERT. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9712123 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2017 DUE TO RIGHT KNEE PAIN, SWELLING, REDNESS AND DRAINAGE FOR 3 DAYS, FEVER, AND DECREASED RANGE OF MOTION. PATIENT HAD PREVIOUSLY HAD RIGHT KNEE REVISION SURGERY ON (B)(6) 2017. PATIENT HAS A COMPLICATED AND LONG SURGICAL HISTORY OF RIGHT KNEE. I AND D AND REVISION OCCURRED ON (B)(6) 2017 DUE TO INFECTION. AT TIME OF REVISION THE SURGEON NOTED COPIOUS AMOUNTS OF OBVIOUS FRANK PUS WITHIN THE KNEE JOINT SPACE. DEVITALIZED TISSUE AND INFECTED TISSUE WAS SEEN THROUGHOUT. THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. MULTIPLE PRODUCTS WERE EXPLANTED AND REPLACED. AT 2 WEEK POST-OP ASSESSMENT ON (B)(6) 2017 PATIENT SHOWS NO SIGN ON INFECTION. THE RIGHT KNEE WOUND IS CONTINUING TO HEAL WITH SOME ERYTHEMA SURROUNDING THE INCISION WHICH APPEARS TO BE SOMEWHAT FROM THE WOUND VAC PLACEMENT, WHICH HAS BEEN REMOVED. THE SWELLING OF THE RIGHT KNEE HAS DECREASED SUBSTANTIALLY.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 6731513 ↗