AEQUALIS DWB248Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03700386915543), received between Dec 6, 2016 and Apr 20, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY WAS UNDERWENT DUE TO A ROTATOR CUFF INSUFFICIENCY.

  Patient problems: Inadequate Osseointegration; Muscle/Tendon Damage

  MAUDE report 16782253 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) EXPLANTED THE GLENOID, THE HUMERAL HEAD AND HUMERAL STEM. HE COMMENTED ON THE SIGNIFICANT WEAR OF THE GLENOID.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9920219 ↗
• InjuryJul 15, 2019Adverse 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 GLENOID WEAR, 5 YEARS AFTER PREVIOUS SURGERY. SUBJECT ID: (B)(6)".

  Patient problems: Osteolysis

  MAUDE report 8789280 ↗
• InjuryMay 15, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GROSS LOOSENING OF GLENOID COMPONENT, 10 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)"

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8611450 ↗
• InjuryApr 12, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC GLENOID LOOSENING 11 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8508784 ↗
• InjuryJan 2, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS 14 YEARS POST-OPERATIVE. SUBJECT ID: (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8207826 ↗
• InjuryOct 4, 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 PAIN 3 YEARS POST-OPERATIVE. PATIENT ID : (B)(4)".

  Patient problems: Pain

  MAUDE report 7933633 ↗
• InjuryApr 26, 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 ROTATOR CUFF INSUFFICIENCY 5 YEARS POST-OPERATIVE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7465262 ↗
• InjuryJun 9, 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 AFTER 12 YEARS FOR LOOSENING/LYSIS. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6629416 ↗
• InjuryJan 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2016: DURING SURGERY, GLENOID WAS FRACTURED. STEM AND HEAD WERE PLACED AND PHYSICIAN DECIDED TO WAIT ABOUT 6 MONTHS. (B)(6) 2016: WHEN THE PHYSICIAN REMOVED THE IMPLANTS TO REPLACE THEM ALL WITH COMPETITORS PRODUCTS, METALLOSIS WAS OBSERVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6218607 ↗
• InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 8 YEARS POST-OPERATIVE DUE TO LOOSENING/LYSIS. CONVERSION INTO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6197854 ↗
• InjuryDec 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 11 YEARS POST-OPERATIVE DUE TO LOOSENING/LYSIS. THE IMPLANTED STEM, HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. CONVERSION INTO (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6148018 ↗