ECHELON 71340413Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010328984), received between Jun 2, 2017 and Nov 3, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 3, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, AFTER THE PATIENT HAD BEEN IMPLANTED AN ECHELON STEM ON (B)(6) 2014 DURING A REVISION SURGERY, THE PATIENT EXPERIENCED A DISLOCATION BECAUSE THE STEM FRACTURED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020: ONLY THE FEMORAL HEAD, STEM AND ACCORD WIRES WERE EXPLANTED. THE PATIENT HAS HAD COMPLICATIONS SINCE THIS PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Failure of Implant; Hip Fracture; Joint Dislocation; Joint Laxity; Metal Related Pathology; Pain; Thromboembolism

  MAUDE report 10781732 ↗
• InjuryFeb 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY NEEDS TO BE PERFORMED DUE TO THE FRACTURE OF THE STEM.

  Patient problems: Injury

  MAUDE report 8327746 ↗
• InjuryAug 7, 2017Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO BREAKAGE OF FEMORAL STEM FOLLOWING A FALL. IT WAS REPORTED THAT BEFORE THE FALL PATIENT HAD SEVERE PAIN.

  Patient problems: Failure of Implant; Fall; Injury; Pain

  MAUDE report 6770295 ↗
• InjuryJun 2, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY WITH EXCHANGE OF FEMORAL STEM. THE PATIENT USED A WALKING STICK TO ASSIST HER, SHE WALKED WITH THE STICK INTO HER LAUNDRY & SLIPPED ON THE WET FLOOR. THIS RESULTED IN A FRACTURE OF THE LEFT FEMUR INCLUDING THE STEM FITTED IN 2000.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 6607655 ↗

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.