NA 86-7421Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295217879), received between Jan 30, 2019 and Oct 6, 2022 — classified as 4 injuries.

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

• InjuryOct 6, 2022Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  HCP IS REPORTING A FRACTURE OF KNEE-TEP´S FEMORAL SLEEVE EXTENSION RIGHT SIDE. DOI: (B)(6) 2021, DOR: (B)(6) 2022.

  Patient problems: Limb Fracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550053 ↗
• InjuryJan 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT'S KNEE WAS REVISED DUE TO HUGENESS AND AN LPS INSERT WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNK, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11155629 ↗
• InjuryAug 22, 2019Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  FRACTURE OF S-ROM NOILES FEMORAL STEM LEFT SIDE. DOI: 2017 IN ANOTHER HOSPITAL. DOR (PLANNED): (B)(6) 2019.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Foreign Body Reaction; No Code Available; No Consequences Or Impact To Patient; Pain

  MAUDE report 8920375 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INCREASED PAIN AND SWELLING.

  Patient problems: No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8289403 ↗