TORNIER PERFORM™ HUMERAL SYSTEM DWP2393Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832084494), received between Sep 6, 2023 and Mar 11, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 29, 2024Class IIOpen, Classified
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Z-3309-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- Failure of Implant1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2024Detachment of Device or Device Component; Device Misassembled During Manufacturing /Shipping; Detachment of Device or Device Component; Device Misassembled During Manufacturing /Shipping
AN ISSUE HAS BEEN REPORTED WITH A PERFORM HUMERAL POLY IMPLANT WHERE THE LOCK RING WAS ASSEMBLED UPSIDE DOWN DURING MANUFACTURING, LEADING TO DISASSEMBLY FROM THE PATIENT IN THE RECOVERY ROOM. IMMEDIATE ACTION WAS TAKEN, WITH THE INSERT BEING REMOVED AND A NEW ONE IMPLANTED. THE REVISION SURGERY WAS SUCCESSFUL WITHOUT ADDITIONAL ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18875665 ↗InjurySep 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A REVISION SURGERY, LARGER GLENOSPHERE AND POLY IMPLANTS WERE USED TO ADDRESS CHRONIC DISLOCATION IN THE PATIENT'S SHOULDER JOINT. IT'S LIKELY THAT THE TEETH OF ONE OF THE INSTRUMENTS, SPECIFICALLY THE GLENOSPHERE REMOVAL TOOL, WERE BENT PRIOR TO THE SURGERY, AS THEY WERE OBSERVED TO BE SLIGHTLY BENT FROM THE OUTSET. THE GLENOSPHERE AND POLY IMPLANTS WERE TORNIER PRODUCTS. HOWEVER, IT'S IMPORTANT TO NOTE THAT THE REVISION SURGERY WAS NOT DUE TO FAULTY IMPLANTS BUT RATHER INSTABILITY ISSUES. THE SURGICAL PROCEDURE ENCOUNTERED DIFFICULTIES INITIALLY DUE TO THE DAMAGED INSTRUMENT BUT PROCEEDED SMOOTHLY AFTER SWITCHING TO ANOTHER SET OF INSTRUMENTS.
Patient problems: Joint Dislocation
MAUDE report 17692912 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- 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 · each recall links to the FDA recall notice
- 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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