TRANSCEND® 26000027Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684260000271), received between May 20, 2019 and Oct 3, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Corroded” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO PAIN FROM UNDERLYING MECHANICAL ASSISTED CREVICE CORROSION FROM MODULAR, COBALT CHROME RIGHT HIP REPLACEMENT WITH AN ELEVATED COBALT LEVELS AND EVIDENCE OF PSEUDOTUMOR ON MRI AND METALLOSIS. THE PRESENCE OF A BLACK RESIDUE PREDOMINANTLY AT THE NECK BODY JUNCTION THAN THE HEAD NECK JUNCTION WAS NOTICED. NON MPO PRODUCTS: ZIMMER BIOMET RB 50 MM ACETABULAR COMPONENT, 50/36 POLYLINER, 25 MM ACETABULAR SCREW.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20361185 ↗
• InjuryMay 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, METALLOSIS AND ASEPTIC CUP LOOSENING.

  Patient problems: Metal Related Pathology

  MAUDE report 19243564 ↗
• InjuryApr 26, 2022Corroded

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO CORROSION AT THE NECK-STEM JUNCTION, PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. DR. (B)(6) REMOVED AND REPLACED THE WRIGHT PROFEMUR COCR MODULAR NECK, WRIGHT ACETABULAR HEAD, AND POLYETHYLENE LINER OF PLAINTIFF'S ARTIFICIAL HIP. PRODUCTS NOT REVISED: PARTID: PHA00242 PROFEMUR® Z FEMORAL STEM S 6 CEMENT LESS/ LOT NUMBER: 0511353146/ QTY:1.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14212833 ↗
• InjuryMay 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY THE PATIENT UNDERWENT RIGHT THR ON (B)(6) 2019, REVISED ON (B)(6) 2019 DUE TO CUP MAL-POSITIONING. THE PATIENT DISLOCATED THREE TIMES FOLLOWING PRIMARY SURGERY. DURING REVISION THE SAME CUP WAS REPOSITIONED, FLAT LINER REPLACED WITH HOODED LINER, LONGER HEAD WAS USED AND A SCREW ADDED. BOTH PROCEDURES WERE PERFORMED THROUGH POSTERIOR APPROACH.

  Patient problems: No Information

  MAUDE report 8623390 ↗