TORNIER PERFORM™ HUMERAL SYSTEM DWP1393Recalls & 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 00846832084432), received between Mar 16, 2023 and Dec 19, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Implant Pain1
- Joint Dislocation1
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS A REVISION DUE TO DISASSOCIATED POLY FROM PERFORM HUMERAL STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851464 ↗InjuryAug 7, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
INSERT DISLOCATED FORWARD. REVISION SURGERY IS PLANNED.
Patient problems: Joint Dislocation
MAUDE report 19929421 ↗InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A CLUNKING IN THE SHOULDER DURING EXTERNAL ROTATION DURING PHYSICAL THERAPY. ACTIVITY WAS MODIFIED TO LIMIT SENSATION OF INSTABILITY IN ER AND A IN PERSON FOLLOW UP WAS SCHEDULED. DURING THE 6 WEEK POST OP, THE PATIENT NOTED THAT THEY "JAMMED HIS SHOULDER AND IT HURT FOR A FEW DAYS" BUT WAS DOING MUCH BETTER. AT THE RESCHEDULED ON (B)(6) 2023 VISIT X-RAYS SHOWED "REVERSE TOTAL SHOULDER ARTHROPLASTY THAT IS REDUCED ALTHOUGH WITH SUBLUXATION OF THE HUMERAL COMPONENT AND LOOSENING; PITON ANCHOR MOVED OUTSIDE OF BONE". LABS TO RULE OUT INFECTION INCLUDING CRP, SED RATE AND CBC WERE COLLECTED AND SHOWED NO INDICATION OF INFECTION. ON A SUBSEQUENT DATE, THE REVISION SURGERY OCCURRED. THE HUMERAL AND LINER COMPONENTS WERE EXTRACTED AND REPLACED WITH A PERFORM LONG STEM AND CONSTRAIN LINER (POLYETHYLENE LINER WAS UNABLE TO BE DISSOCIATED FROM THE HUMERAL COMPONENT). SUBJECT IN STABLE CONDITION POSTOPERATIVELY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 16552660 ↗
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
- 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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