NA 86-7420Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295217862), received between Dec 13, 2017 and Sep 16, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS COMPETITOR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20223148 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE IMPLANTS WERE EXPLANTED DUE TO NICKEL ALLERGY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17611805 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FEMORAL REVISION ONLY AND CONVERSION TO A HINGED FEMORAL PROSTHESIS DUE TO MEDIAL COLLATERAL INSTABILITY. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15996052 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517252 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT THE PATIENT WAS REVISED IN 2018 WITH A THICKER POLY (THICKEST AVAILABLE). PATIENT COMPLAINING OF PAIN IN KNEE AND NOT FEELING STABLE. SURGEON OPTED FOR SURGERY TO REVISE TIBIA, REMOVING TRAY STEM AND SLEEVE. REPLACED WITH A THICK TRAY, BIGGER SLEEVE, STEM AND NEW POLY TO GAIN BETTER BALANCE. SURGERY WAS SUCCESSFUL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12338579 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. NO SURGICAL DELAY REPORTED DOI: (B)(6) 2017, DOR: (B)(6), 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11455600 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS REVISION DUE TO LOOSENING, INFECTION AND FRACTURE (LOOSENING AND FRACTURE ARE UNSPECIFIED). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10726995 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A KASM ANTIBIOTIC SPACER WAS IMPLANTED. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE. HERE ARE THE FINAL 4 EXPLANTED IMPLANTS: 96-0901 LOT #D39FB4, 96-0901 LOT #H19755, 96-0908 LOT #HH7455, 96-0908 LOT # H08683. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9637181 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTED LEFT KNEE. LPS POLY INSERT WAS EXCHANGED. WASH OUT AND I&D WERE PERFORMED IT WAS REPORTED AT (B)(4). REVISED REPORT: PATIENT WENT ON TO HAVE A LEFT ABOVE KNEE AMPUTATION. ADDING IMPLANTS TO REPORT THAT WERE TAKEN OUT AT TIME OF AMPUTATION ON (B)(6) 2019. THESE WERE ORIGINALLY IMPLANTED (B)(6) 2019. DOI: (B)(6) 2019, (LPS UNIV TIB HIN INS XSM 16 MM). DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8864557 ↗
• InjuryJun 28, 2019Fracture; Fracture

  PATIENT WAS REVISED TO ADDRESS PAIN. RECENTLY PATIENT WAS SEEN IN THE CLINIC BY THE SURGEON SAYING THAT HE HEARD SOMETHING SNAP IN HIS LEG. X-RAY SHOWED WHAT WOULD APPEAR TO BE A BREAK AT THE JUNCTION BETWEEN THE FEMORAL SLEEVE AND UNIVERSAL STEM. PATIENT WAS TOLD TO STAY OFF LEG AND WE WOULD PLAN AN ADDITIONAL REVISION SURGERY. PATIENT APPARENTLY DIDN'T TAKE ADVICE AND WENT TO WORK NEXT DAY. A FEW DAYS LATER RETURNED TO HOSPITAL WITH A PAINFUL LEFT LEG. X-RAY SHOWED A FRACTURED FEMUR AT THE LOCATION OF THE IMPLANT BREAK. THE TEAM REMOVED ALL THE FEMORAL IMPLANTS AND REVISED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 8745446 ↗
• InjuryJun 7, 2019Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PATIENT WAS REVISED TO ADDRESS MALFORMATION OF THE LOWER LEG IN FLEXION DUE TO LOOSENING OF THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. LPS DISTAL FEMUR WAS IMPLANTED FOR TREATMENT OF COMMINUTED DISTAL FEMUR FRACTURE. DURING THE REVISION SURGERY , IT REVEALED A LOOSE FEMORAL SLEEVE THAT WAS DISCONNECTED TO THE STEM. IMPLANTS WERE REMOVED, STEM WAS EXCHANGED WITH A CEMENTED STEM AND REIMPLANTED. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8678491 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REC'D: ALERT DATE 11-27-2017. AE RECEIVED FOR INTRA-OPERATIVE COMPLICATION OF FEMORAL BONE FRACTURE. EVENT DOES MEET THE DEFINITION OF SERIOUS. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. TREATMENT INCLUDES ORIF WITH CABLE AND SCREW FIXATION OF DISTAL FEMORAL FRACTURE. DOE: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7147380 ↗
• InjuryDec 13, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AT UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2017; DOR: (B)(6) 2017 UNKNOWN AFFECTED SIDE.

  Patient problems: Pain

  MAUDE report 7115603 ↗