TORNIER PERFORM™ HUMERAL SYSTEM DWR4420Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of TORNIER PERFORM HUMERAL SYSTEM (68)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832085057), received between Jul 18, 2024 and Aug 21, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Positioning Failure1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT LIFTED ARM AND HEARD A POP. PATIENT UNDERWENT A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 22865226 ↗MalfunctionJul 18, 2024Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component
THE ANSM REPORTED THE FOLLOWING EVENT: "UNABLE TO FULLY IMPACT THE 10° RETENTIVE INSERT, THERE WAS A PERSISTENT "GAP" BETWEEN THE INSERT AND THE PERFORM STEM. ON REMOVAL, IT BECAME APPARENT THAT THE METAL RING HAD SHIFTED TO THE RIGHT. DURING THE IMPACTION PROCEDURE. WHAT MEASURES/ACTIONS WERE TAKEN TO COMPLETE THE PROCEDURE? THE SURGEON CHANGED THE HUMERAL STEM (FROM A 4-SHORT STEM TO A 4+-LONG STEM) AND THE INSERT (FROM A 10° RETENTIVE ¾ 0 INSERT TO A SYMMETRICAL RETENTIVE ¾ 0 INSERT)."
Patient problems: Failure of Implant
MAUDE report 19774342 ↗
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- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
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- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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