Tornier Flex Shoulder System DWH152Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700434021387), received between Nov 8, 2024 and Mar 10, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24556767 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THIS PATIENT UNDERWENT MULTIPLE ARTHROPLASTY PROCEDURES, IN NEW ZEALAND, AFTER SUFFERING AVASCULAR NECROSIS OF BOTH HUMERAL HEADS AND FEMORAL HEADS, SECONDARY TO CHEMOTHERAPY (FOR TREATMENT OF LEUKEMIA). HE HAS HAD BILATERAL TOTAL HIP REPLACEMENTS, AND BILATERAL SHOULDER REPLACEMENTS. THE EXACT DETAILS - HOSPITALS / SURGEON/S / DATES / IMPLANTS, ETC., IS NOT KNOWN. PATIENT'S LEFT SHOULDER REPLACEMENT (PRIMARY SURGERY APPROX. 7 YEARS AGO), EXPERIENCED A S. AUREUS INFECTION, APROX. 5 YEARS AGO, ACCORDING TO SURGEON. THIS WAS RESOLVED. PT MIGRATED TO AUSTRALIA SEVERAL YEARS AGO. EARLIER THIS YEAR, PT BEGAN EXPERIENCING DISCOMFORT IN THIS LEFT SHOULDER, WHICH WAS INITIALLY THOUGHT TO BE A WORK-RELATED INJURY ... UNDERWENT REHAB / PHYSIO THROUGH QLD. WORK COVER. REFERRED TO PA HOSPITAL FOR FURTHER INVESTIGATION, WHEN SYMPTOMS DID NOT RESOLVE. CLINICAL MARKERS INDICATE POSSIBLE INFECTION IN THIS LEFT PROSTHETIC SHOULDER JOINT (PATIENT IS HEAVILY TATTOOED). DURING OPEN PROCEDURE YESTERDAY, SURGEON BELIEVED THERE WAS LIKELY INFECTION INSITU - MULTIPLE TISSUE SPECIMENS TAKEN, AND ALL PROSTHESIS REMOVED, WHICH INCLUDED A SIZE 2 ASCEND FLEX HUMERAL PTC STEM, AND A 52 X 19 PYROCA

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 20643816 ↗