TORNIER PERFORM™ HUMERAL SYSTEM DWX1PLRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832085385), received between Dec 27, 2022 and Nov 25, 2025 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Osseointegration Problem1
Patient problems
- Fever1
- Implant Pain1
- Inadequate Osseointegration1
- Joint Dislocation1
- Joint Impingement1
- Nonunion/Delayed-union Bone Fracture1
- Subluxation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT, THE STEM WAS LOOSENING. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Inadequate Osseointegration
MAUDE report 23649270 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). SHOULDER ID STUDY AS REPORTED: PATIENT REPORTED A "CATCHING" FEELING IN SHOULDER WITH INCREASED PAIN SINCE 06 JUN 24. PT ALSO HAD A FEVER ON 16 JUN 2024; ANTIBIOTICS WERE PRESCRIBED FOR THIS. AS OF 25 JUN 24, THE PATIENT REPORTED THAT HER SHOULDER PAIN IS IMPROVING.
Patient problems: Fever; Implant Pain; Joint Impingement
MAUDE report 19833200 ↗InjuryDec 27, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS AN INSTABILITY/ SUBLUXATION WITH THE IMPLANT IN THE RIGHT SHOULDER WITH FAILURE OF THE SUBSCAPULARIS REPAIR. THIS SUBJECT WAS CONVERTED FROM AND ANATOMIC TO A REVERSE AS A RESULT OF THIS AE.
Patient problems: Joint Dislocation; Nonunion/Delayed-union Bone Fracture; Subluxation
MAUDE report 16057384 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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