TORNIER PERFORM™ HUMERAL SYSTEM DWR1396Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832084807), received between Mar 11, 2022 and Mar 11, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Fall1
- Implant Pain1
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS HAPPY WITH HIS PROGRESS AND PERFORMING ACTIVITIES OF DAILY LIVING WITHOUT COMPLAINT POST RSA IN (B)(6) OF 2020. THE PATIENT HAD A 39 STANDARD GLENOSPHERE ON A 29 +3 BASEPLATE WITH A LONG POST. ON THE HUMERAL SIDE HE HAD A 2+ STEM AND A 10 DEGREE ½ 39 +6 POLY. THE PATIENT HAD A FALL. HE HAD PAIN AND LIMITED FUNCTION AFTER THE FALL. THE PATIENT WAS SEEN IN THE ER AND APPEARED TO HAVE A POLY DISSOCIATION. REVISION SURGERY WAS SCHEDULED FOR LATER THAT DAY ((B)(6) 2022). REVISION SURGERY ((B)(6) 2022): THE POLY WAS COMPLETELY OUT OF THE STEM. THE RING WAS RETAINED WITHIN THE STEM. BOTH THE POLY AND LOCKING RING WERE REMOVED. A SPACER WITH +0 POLY WAS TRIALED WITH GOOD STABILITY AND MOTION. THIS WAS IMPLANTED IN THE PATIENT.
Patient problems: Fall; Implant Pain; Loss of Range of Motion
MAUDE report 13734685 ↗
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- 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
- 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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