AEQUALIS REVERSED DWD003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386928222), received between Jul 15, 2019 and Jan 10, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). SHOUT - TORNIER SHOULDER OUTCOMES STUDY. CONSIDERABLE ONGOING LEFT SHOULDER PAIN AND INCREASING LEFT AXILLARY PAIN. NO INJURY. ON (B)(6) 2021, SUBJECT FIRST REPORTED CONSIDERABLE LEFT SHOULDER PAIN. X-RAYS AND PHYSICAL EXAM WERE NORMAL WITHOUT ANY EVIDENCE OF COMPLICATION. HE WAS INSTRUCTED TO RETURN IN 1 YEAR FOR ANNUAL FOLLOW UP. ON (B)(6) 2022, HE REPEATED THESE COMPLAINTS. YET AGAIN, X-RAYS DID NOT REVEAL EVIDENCE OF LOOSENING. SURGEON ATTEMPTED ASPIRATION TO SEND FOR CULTURE BUT WAS UNABLE TO OBTAIN ANY FLUID. SUBJECT WAS SENT FOR CBC, ESR, AND CRP LABS. SURGEON THOUGHT INFECTION WAS UNLIKELY BUT WANTED TO INVESTIGATE ALL POTENTIAL CAUSES FOR ONGOING PAIN. ON (B)(6) 2022, SUBJECT RETURNED WITH CONTINUED COMPLAINTS OF PAIN, ESPECIALLY AROUND THE PECTORALIS INSERTION AND TO A LESSER DEGREE IN THE BACK OF THE SHOULDER. HE COMPLAINED OF SOME MECHANICAL SYMPTOMS ESPECIALLY AT NIGHTTIME, WHEN HE IS POSITIONED IN BED, AND WITH MOTION. INFLAMMATORY LAB WORKUP WAS NEGATIVE. DR. (B)(6) SUGGESTED CT SCAN TO RULE OUT MECHANICAL COMPLICATIONS. ON (B)(6) 2022, SUBJECT RETURNED FOR CT REVIEW, WHICH DID NOT SHOW ANY MECHANICAL COMPLICATIONS. SURGEON STATED THAT

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 21122537 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAIN IS TRAVELING AND IS SO SEVERE AT TIMES. ALL INTO NECK AND DOWN ARM. SURGERY IN 2016 GOT BETTER BUT 6 MONTHS AGO, MY ARM IS MUCH MORE PAINFUL. I HAVE 105 + 2 LOT OF MOBILITY IN IT. CAN'T AFFORD TO GO TO DR AND CHECKED. I AM ON. WAS DOING REALLY GOOD ON HEALING. 6 MONTHS AGO STARTED GETTING WEAKER. THE PAIN IS ALL THE WAY INTO NECK AND MY HAND IS NUMB AND TINGLING. ELBOW PAIN. CAN'T AFFORD TO GO TO DOCTOR.

  Patient problems: Pain

  MAUDE report 13606757 ↗
• MalfunctionJun 16, 2021Difficult to Insert; Difficult to Insert

  THE SPHERE DID NOT ENGAGE WITH THE BASEPLATE WHEN THE SPHERE WAS IMPACTED ONTO THE BASEPLATE. BOTH COMPONENTS (THE SPHERE & BASEPLATE) WERE LEFT IN THE PATIENT. SURGEON TRIED SEVERAL TIMES TO ENGAGE THE SPHERE WITH THE BASEPLATE. THE DWD167 SCREWDRIVER WAS USED TO ASSEMBLE THE BASEPLATE AND GLENOSPHERE TOGETHER. THERE WAS A 3-5 MINUTE DELAY. THIS EVENT WAS A PRIMARY SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011061 ↗
• InjuryJul 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT WHO HAD AN INITIAL SURGERY OF THE AEQUALIS REVERSE ON (B)(6) 2015, VISITED THE OUTPATIENT DEPARTMENT ON (B)(6) 2020,AND COMPLAINED OF PAIN IN THE AFFECTED AREA. UPON X-RAY EXAMINATION AND PUNCTURE EXAMINATION OF THE AFFECTED AREA, LOOSENESS OF GLENOID IMPLANT AND INFECTION WERE CONFIRMED. SURGERY WAS PERFORMED ON (B)(6) 2020. SINCE THE BASE PLATE ON THE GLENOID SIDE WAS UNSTABLE, ALL IMPLANTS ON THE GLENOID SIDE WERE REMOVED EXCEPT THE HUMERAL STEM IMPLANT AND THE METAPHYSIS IMPLANT, AND THE SURGERY WAS COMPLETED. THE SURGEON COMMENTED:REGARDING THE IMPLANT ON THE HUMERAL SIDE WAS CONFIRMED TO BE STABLE, SO IT WAS LEFT AS IT WAS.

  Patient problems: Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 10238768 ↗
• InjuryJul 15, 2019Malposition of Device; Malposition of Device

  AFTER THE SURGERY OF ASCEND FLEX RSA, BECAUSE THE FIXED POSITION OF THE SPHERE WAS NOT GOOD, SCAPULAR NOTCHING OCCURRED IN THE AFFECTED AREA. REVISION SURGERY PERFORMED ON (B)(6) 2019.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8788849 ↗