FLEX SHOULDER SYSTEM DWF043Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386940040), received between Jan 4, 2017 and Aug 17, 2021 — classified as 5 injuries.

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

• InjuryAug 17, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER SURGERY. SOMETIME POST-OP, THE PATIENT NOTICED A LUMP ON THE ANTERIOR SHOULDER. A CT SCAN SHOWED METAL DEBRIS. THE PATIENT UNDERWENT A REVISION SURGERY.

  Patient problems: Foreign Body In Patient; Granuloma

  MAUDE report 12332635 ↗
• InjurySep 17, 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 ANTEROSUPERIOR ESCAPE. STEM RETAINED FROM PREVIOUS SURGERY. ASCEND FLEX ANATOMIC TOTAL CONVERTED INTO ASCEND FLEX REVERSED. PATIENT ID: (B)(6)"

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 9079525 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WILL NEED A REVISION SURGERY DUE TO PAIN AND LOSS OF RANGE OF MOTION. PATIENT ID: (B)(4).

  Patient problems: Pain

  MAUDE report 7082146 ↗
• InjuryMar 6, 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 FOR ROTATOR CUFF INSUFFICIENCY. CONVERSION TO REVERSE SHOULDER ARTHROPLASTY. THE STEM FORM PREVIOUS SURGERY REMAINED IMPLANTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6379867 ↗
• InjuryJan 4, 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 FOR ROTATOR CUFF INSUFFICIENCY. CONVERSION TO REVERSE SHOULDER ARTHROPLASTY. PRIOR STEM RETAINED, USED LOW OFFSET +0 TRAY WITH +9 POLY INSERT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6221082 ↗