AEQUALIS™ PerFORM DWE301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386937330), received between Oct 13, 2016 and May 28, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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.

• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE INITIAL SURGERY OF AEQUILES PERFORM GLENOID WAS PERFORMED. AT THIS TIME, BONE CYSTS WERE CONFIRMED IN THE GLENOID, BUT THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. DURING THE PERIODIC HEALTH EXAMINATION ON (B)(6) 2020, EVERSION AT THE AFFECTED PART WAS CONFIRMED. IT HAD A LITTLE PAIN TOO. ON (B)(6) 2020, SURGERY WAS COMPLETED BY REMOVING ONLY THE PEG GLENOID. THE STEM IMPLANT ON THE HUMERAL SIDE WAS NOT LOOSENED, BUT THE GLENOID WAS SLIGHTLY DEFORMED. THE SURGEON COMMENTED THAT HE WANTED TO KNOW IF THE CAUSE OF EVERSION WAS DUE TO INSTABILITY OF THE PEG GLENOID DUE TO LACK OF CEMENT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 10095464 ↗
• InjuryDec 23, 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 ROTATOR CUFF INSUFFICIENCY ASSOCIATED WITH PAIN AND LOSS OF RANGE OF MOTION 3 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)."

  Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Pain

  MAUDE report 9509315 ↗
• InjuryDec 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "(B)(6) 2017, INITIAL SURGERY OF ''AEQUALIS PERFORM GLENOID'' WAS PERFORMED. AFTER THE SURGERY, THE PATIENT VISITED THE HOSPITAL SEVERAL TIMES, BUT THERE WAS NO ABNORMALITY. IN THE MEANTIME, HE FELL DOWN SEVERAL TIMES AND HAD AN X-RAY EXAMINATION IN (B)(6) 2019, BUT FOUND NO PROBLEM. (B)(6) 2019, THE PATIENT VISITED THE HOSPITAL FOR PAIN AND AFTER THE EXAMINATION, IT WAS CONFIRMED THAT THE GLENOID PEG HAD FALLEN OUT. (B)(6) 2019, REVISION SURGERY WAS PERFORMED. THE FOUR HOLES FOR THE GLENOID PEG LOOKED GOOD AND ONLY THE GLENOID PEG WAS FALLED OUT, BUT IT WASN'T DEFORMED OR DAMAGED. SINCE THE CAUSE WAS UNKNOWN, IT WAS JUDGED THAT THE PEG GLENOID SHOULD NOT BE ADDED AGAIN, AND THE SURGERY WAS COMPLETED AND THE GLENOID AREA WAS LEFT AS IT WAS."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9450110 ↗
• InjuryOct 13, 2016Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 9 MONTHS POST-OPERATIVE DUE TO ROTATOR CUFF TEAR AND LOOSENING OF THE STEM. THE IMPLANTED STEM, HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. CONVERSION INTO RSA. SURGEON'S COMMENT: HE SHOULD HAVE DONE RSA INSTEAD OF TSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6025999 ↗