ECHELON 71340612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010383969), received between Apr 3, 2019 and Apr 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2020Break; Break

  IT WAS REPORTED THAT THE FEMORAL STEM USED IN THE PATIENT WHO UNDERWENT REVISION HIP SURGERY ON (B)(6) 2018 BROKE ON (B)(6) 2020. PATIENT REPORTED THAT THE BREAKAGE OCCURRED WHILE RETURNING TO SLEEP.

  Patient problems: Injury

  MAUDE report 9931455 ↗
• InjuryApr 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR REMOVAL OF A SMITH&NEPHEW PROSTHESIS FROM THE LEFT KNEE OF A PATIENT DUE TO INCREASED PROBLEMS CAUSED BY THE PROSTHESIS, WHICH BROKE IN THE PAST AND WAS PATCHED INSIDE THE PATIENT.

  Patient problems: Injury

  MAUDE report 8479399 ↗

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.