TRANSCEND® 26000018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684260000181), received between Jan 14, 2021 and Jun 24, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, REVISION WAS PERFORMED FOR A CASE OF PROLAPSE. THE BIPOLAR CUP SIDE WAS DAMAGED BEFORE REVISION, CAUSING THE PATIENT'S PROLAPSE. DOCTOR'S FINDING: THE BIPOLAR CUP SIDE WAS DAMAGED (RING DEFORMATION) BEFORE THE REVISION, WHICH MAY HAVE CAUSED THE PATIENT'S PROLAPSE. REPORTING PARTY'S FINDINGS AND RESPONSE: THE RING IN THE OUTER CUP WAS DEFORMED AND SEEMED TO BE LOOSE, SO THE CUP AND HEAD WERE REPLACED. JAPAN - (B)(4).

  Patient problems: Prolapse

  MAUDE report 14800107 ↗
• InjuryJan 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT UNDERWENT RIGHT THR ON (B)(6) 2020. REVISED ON (B)(6) 2020 DUE TO DISLOCATION. SURGEON REPORTS THE DISLOCATION IS MOST LIKELY DUE TO NEUTRAL VERSION OF THE CUP PLACEMENT. PATIENT REVISED WITH A +7 COCR HEAD AND A 15 DEGREE LIP LINER. (B)(6).

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11171474 ↗