AEQUALIS RESURFACING HEAD DWD804Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700386926945), received between Jun 14, 2016 and Feb 25, 2022 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2022Off-Label Use; Off-Label Use

  IMPLANT WAS EXPIRED. SURGEON DECIDED TO IMPLANT EXPIRED IMPLANT. NO BACKGUP IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606727 ↗
• InjuryFeb 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT HAD A HUMERAL COMPONENT LOOSENING 13 YEARS AFTER PRIMARY SURGERY, THE REVISION IS SCHEDULED ON (B)(6) 2020, PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9698953 ↗
• InjurySep 18, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "GROSS LOOSENING OF GLENOID WITH MIGRATION INTO AXILLARY RECESS. LOOSENING OF HUMERAL HEAD COMPONENT WITH NOTCHING OF THE MEDIAL PROXIMAL HUMERUS JUST BELOW THE IMPLANT. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7884672 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR LOOSENING/LYSIS AT 8 YEARS POST-OPERATIVE. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7560079 ↗
• InjuryFeb 16, 2018Material Erosion; Material Erosion

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO WEAR-GLENOID, 6 YEARS POST-OPERATIVE. PATIENT ID : (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7276396 ↗
• InjuryJan 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT 2 YEARS POST-OP DUE TO PROGRESSION OF DISEASE. CONVERSION HEMI TO TSA. PATIENT (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6272789 ↗
• InjuryDec 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO MALPOSITION. CONVERSION TO TSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6202019 ↗
• InjuryAug 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROSCOPIC SURGERY FOR SEVERE POST-OPERATIVE STIFFNESS. BIOLOGICAL RESURFACING OF THE GLENOID. AT A CLINICAL VISIT ON (B)(6) 2016, THE PATIENT STATED SHE HAD BEEN HAVING A LOT OF PROBLEMS WITH POST-OPERATIVE STIFFNESS AND LIKELY CAPSULITIS. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5871509 ↗
• InjuryJun 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "REVISION SURGERY DUE TO LOOSENING/LYSIS". A TORNIER AEQUALIS RESURFACING HEAD COMPONENT WAS REMOVED AND REPLACED BY A TORNIER REVERSED PROSTHESIS. REVISION SURGERY DATE (B)(6) 2016. PRIMARY SURGERY(B)(6) 2010. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5722682 ↗