AEQUALIS RESURFACING HEAD DWD806Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386926969), received between Jul 20, 2016 and Apr 15, 2022 — classified as 4 injuries.

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 18, 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.

• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE COMPLICATION DESCRIBED AS SUB ACROMIAL IMPINGEMENT DUE TO ACROMIAL SPUR. "PATIENT COMPLAINING OF SEVERE PAIN WITH MOVEMENT. CT ARTHROGRAM REVEALED AN ACROMIAL OSTEOPHYTE CAUSING IMPINGEMENT." THE PATIENT UNDERWENT A SECOND RE-OPERATION WITHOUT COMPONENT CHANGE: ARTHROSCOPIC PROCEDURE CONSISTING OF AN EXTENSIVE DEBRIDEMENT, ADHESIOLYSIS, PANCAPSULAR RELEASE, SUB ACROMIAL DECOMPRESSION, AND SUB CORACOID OSTEOPHYTE REMOVAL.

  Patient problems: Bacterial Infection; Implant Pain

  MAUDE report 14119389 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE COMPLICATION. THE PATIENT HAD TO UNDERGO RE-OPERATION WITHOUT COMPONENT CHANGE: ARTHROSCOPIC DEBRIDEMENT, ADHESIOLYSIS BIOPSIES FOR CULTURES AND SUB ACROMIAL DECOMPRESSION, SHOWING 2 POSITIVE BACTERIAL CULTURES (1 FOR C ACNES AND 1 FOR GRAM POSITIVE RODS). PATIENT HAS BEEN TREATED WITH ANTIBIOTICS. THE ADVERSE EVENT IS STILL ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 14119388 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE COMPLICATION DESCRIBED AS SUBACROMIAL IMPINGEMENT DUE TO ACROMIAL SPUR."PATIENT COMPLAINING OF SEVERE PAIN WITH MOVEMENT. CT ARTHROGRAM REVEALED AN ACROMIAL OSTEOPHYTE CAUSING IMPINGEMENT."

  Patient problems: Adhesion(s); Implant Pain

  MAUDE report 14115928 ↗
• InjuryJul 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "REVISION SURGERY AT 5.5 YEARS POST-OP FOR PROGRESSION OF DISEASE ". A TORNIER AEQUALIS RESURFACING HEAD COMPONENT WAS REMOVED. REVISION SURGERY DATE (B)(6) 2016. PRIMARY SURGERY (B)(6) 2010. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5807976 ↗