ECHELON 71340113Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010328724), received between Nov 19, 2018 and Feb 5, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K211176, K983834); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED, THE ECH POR 190MM STR SZ 13 THAT WAS IMPLANTED, BROKE. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. NO MEDICAL INTERVENTION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 16302053 ↗
• InjuryJan 31, 2023Fracture; Fracture

  IT WAS REPORTED, FOUR YEARS AFTER A THR SURGERY HAD BEEN PERFORMED ON 2014, THE PATIENT EXPERIENCED SUDDEN ONSET OF THIGH PAIN AND INABILITY TO WALK. THE PATIENT WENT TO THE HOSPITAL WITH PAIN ON (B)(6) 2022. AS A RESULT OF THE EVALUATION OF THE PATIENT, X-RAYS WERE TAKEN ON (B)(6) 2022 AND SHOWED THAT THE ECHELON 190MM POROUS FEMORAL COMPONENT SIZE 13 WAS FRACTURED. THIS WAS ADDRESSED VIA REVISION SURGERY TO EXPLANT THE STEM, THE DATE OF THE REVISION IS NOT KNOWN. CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 16273473 ↗
• InjuryJun 3, 2020Break; Break

  IT WAS REPORTED THAT CLAIMANT WAS INITIALLY IMPLANTED WITH A RECALLED STRYKER TMZF DEVICE ON (B)(6) 2008. HE WAS REVISED ON (B)(6) 2015 IN (B)(6), WHEN THE ECHELON REVISION STEM WAS IMPLANTED. THE ECHELON STEM FRACTURE WAS SHOWN ON X-RAY ON (B)(6) 2017 BUT IT STEM WASN'T REVISED UNTIL 6 WEEKS LATER, ON (B)(6) 2017.

  Patient problems: Injury

  MAUDE report 10114110 ↗
• InjuryNov 23, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 8099908 ↗
• InjuryNov 19, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BROKEN PROTHESIS. THE PLACEMENT OF THIS PROSTHESIS WAS A 3RD REVISION FOR A (B)(6) PATIENT.

  Patient problems: Injury

  MAUDE report 8083827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K983834. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.