PERFORM™ HUMERAL SYSTEM DWS2390Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832078080), received between Aug 17, 2022 and Sep 29, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 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.

• InjurySep 29, 2026Unstable

  As reported: "Patients shoulder became unstable six months after initial RSA surgery so surgeon performed a revision surgery to exchange the 39mm Glenosphere and 45% reverse poly insert."

  Patient problems: Joint Laxity

  MAUDE report 50934508 ↗
• InjuryJun 22, 2026Unstable; Device Dislodged or Dislocated

  THE PATIENT EXPERIENCED RECURRENT SHOULDER DISLOCATION/INSTABILITY FOLLOWING A PREVIOUSLY IMPLANTED REVERSE TOTAL SHOULDER ARTHROPLASTY. TO ADDRESS THE INSTABILITY, THE SURGEON PERFORMED A REVISION PROCEDURE CONSISTING OF AN INSERT EXCHANGE, REVISING THE INSERT FROM DWS2390 TO DWR4393.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25587128 ↗
• MalfunctionFeb 26, 2024Positioning Failure; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS CONDUCTED IN RESPONSE TO AN INFECTION. AN UPDATE PROVIDED INDICATES A LACK OF INFORMATION REGARDING THE LOT NUMBERS FOR THE SCREWS USED. HOWEVER, IT WAS MENTIONED THAT THE INFECTION APPEARED TO BE LOCALIZED, AND THE PROCEDURE INVOLVED WASHING OUT AND EXCHANGING PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 18779116 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SINCE THE SURGERY, SHE HAS BEEN UNABLE TO USE HER RIGHT HAND/WRIST. PHYSICIAN POST-OP EXAMINATION RESULTED IN A DIAGNOSIS OF RADIAL NERVE PALSY.

  Patient problems: Paralysis

  MAUDE report 15245001 ↗