FLEX SHOULDER SYSTEM DWF422BRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03700386940897), received between Jun 15, 2016 and Aug 10, 2021 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A PERIPROSTHETIC INFECTION 6 WEEKS AFTER INITIAL SURGERY. RE-OPERATION WITHOUT COMPONENT CHANGE (IRRIGATION AND DEBRIDEMENT, MEDICATION IV DAPTOMYCIN AND NOW CHRONIC SUPPRESSION WITH DOXYCYCLINE)

  Patient problems: Unspecified Infection

  MAUDE report 12304992 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FULL REVISION CASE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11633042 ↗
• InjuryJun 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ANTEROSUPERIOR ESCAPE, 1 YEAR AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)".

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 8716316 ↗
• InjuryNov 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WE DID A PRIMARY REVERSE ON A PATIENT IN (B)(6) ON (B)(6) WITH DR (B)(6). PATIENT HAD A HISTORY OF FALLS AND WAS GENERALLY NON COMPLIANT. PT DISLOCATED AND WE CHANGED THE 42X6MM POLY TO A 42X9MM POLY ON (B)(6). PT DISLOCATED AGAIN AND WE REVISED THIS PT AGAIN ON (B)(6). THIS TIME WHEN THE DOC OPENED THE PATIENT, THE REVERSE TRAY AND THE POLY WERE DISASSOCIATED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7066489 ↗
• MalfunctionJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY/DISLOCATION. STEM, TRAY AND INSERT WERE REMOVED AND REPLACED DURING SURGERY, BASEPLATE AND GLENOSPHERE REMAINED THE SAME FROM PREVIOUS SURGERY (1ST STAGE).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6642655 ↗
• InjuryMay 16, 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 15 MONTHS POST-OPERATIVE DUE TO INSTABILITY/DISLOCATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6569224 ↗
• InjuryNov 29, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR INSTABILITY/DISLOCATION. THE IMPLANTED REVERSED TRAY AND REVERSED INSERT WERE REMOVED. STEM, BASEPLATE AND GLENOSPHERE REMAINED FROM PREVIOUS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6131871 ↗
• InjuryNov 16, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT 3 MONTHS POST-OP DUE TO INSTABILITY/DISLOCATION. THE IMPLANTED STEM, REVERSED TRAY AND INSERT WERE REMOVED. BASEPLATE AND GLENOSPHERE REMAINED FROM PREVIOUS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6105433 ↗
• InjuryAug 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR HUMERUS PERI-PROSTHETIC FRACTURE. NON HEALED AND INCREASED PAIN DESPITE BONE SIMULATOR. REVISION ORIF AND STRUT GRAFT. GREATER AND LESSER TUBEROSITY REPAIR. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5906192 ↗
• InjuryJun 15, 2016Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn

  PATIENT WAS EXPERIENCING PAIN. REVISION SURGERY AT 20 MONTHS POST-OPERATIVE.

  Patient problems: Pain

  MAUDE report 5725684 ↗