PERFORM HUMERAL SYSTEMRecalls & reported problems across all models
Tornier, Inc. · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 21 models of PERFORM HUMERAL SYSTEM by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between May 6, 2021 and Sep 29, 2026 — classified as 29 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PERFORM HUMERAL SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Device Dislodged or Dislocated11
- Unstable6
- Positioning Failure2
- Device Difficult to Setup or Prepare1
- Inadequacy of Device Shape and/or Size1
- Off-Label Use1
- Osseointegration Problem1
Patient problems
- Joint Dislocation9
- Joint Laxity7
- Bone Fracture(s)6
- Pain4
- Insufficient Information3
- Loss of Range of Motion3
- No Clinical Signs, Symptoms or Conditions3
- Implant Pain2
PERFORM HUMERAL SYSTEM models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PERFORM™ HUMERAL SYSTEM DWS1360prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- PERFORM™ HUMERAL SYSTEM DWS2390prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- PERFORM™ HUMERAL SYSTEM DWP1390shoulder prosthesis, reverse configuration2 reports
- PERFORM™ HUMERAL SYSTEM DWS2360prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- PERFORM™ HUMERAL SYSTEM DWS3363prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- PERFORM™ HUMERAL SYSTEM DWT4366prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- PERFORM™ HUMERAL SYSTEM DWP2420shoulder prosthesis, reverse configuration1 report
- PERFORM™ HUMERAL SYSTEM DWS1363prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS1390prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS2363prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS2420prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS2426prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS3360prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS3390prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS4360prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS4390prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS4396prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT1363prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT2420prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT4393prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT4423prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
Recent PERFORM HUMERAL SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Unstable
As reported: "Patients shoulder became unstable six months after initial RSA surgery so surgeon performed a revision surgery to exchange the 39mm Glenosphere and 45% reverse poly insert."
Patient problems: Joint Laxity
MAUDE report 50934508 ↗MalfunctionSep 25, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905585 ↗InjurySep 8, 2026Device Dislodged or Dislocated
Revision surgery was performed as the result of the poly disassociating from the stem.
Patient problems: Joint Dislocation
MAUDE report 50674220 ↗InjuryAug 24, 2026Device Dislodged or Dislocated
It was reported that the patient's shoulder dislocated; revision surgery planned.
Patient problems: Joint Dislocation
MAUDE report 50414191 ↗InjuryJul 28, 2026Device Dislodged or Dislocated
It was reported that the patient's Right shoulder was revised due to separation of the poly implant from the stem. A poly exchange was performed (stem was retained).
Patient problems: Insufficient Information
MAUDE report 50054860 ↗InjuryJun 22, 2026Unstable; Device Dislodged or Dislocated
THE PATIENT EXPERIENCED RECURRENT SHOULDER DISLOCATION/INSTABILITY FOLLOWING A PREVIOUSLY IMPLANTED REVERSE TOTAL SHOULDER ARTHROPLASTY. TO ADDRESS THE INSTABILITY, THE SURGEON PERFORMED A REVISION PROCEDURE CONSISTING OF AN INSERT EXCHANGE, REVISING THE INSERT FROM DWS2390 TO DWR4393.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25587128 ↗InjuryFeb 25, 2026Off-Label Use
WHILE COVERING A REVERSE SHOULDER PROCEDURE A 1/2 36+3 POLY WAS OPENED AND IMPLANTED. THIS DID NOT MATCH THE 39 GLENOSPHERE THAT WAS USED ON THE GLENOID. IT WAS DISCOVERED HOURS AFTER THE SURGERY. THE PATIENT WAS TAKEN BACK IN THE FOLLOWING MORNING TO PUT THE CORRECT MATCHING IMPLANT IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24448055 ↗InjuryJan 14, 2026Device Dislodged or Dislocated
BELIEVED THE POLYETHYLENE COMPONENT WAS PROPERLY SEATED INTRAOPERATIVELY. POSTOPERATIVELY, THE POLYETHYLENE WAS FOUND TO HAVE DISENGAGED, INDICATING A POTENTIAL ISSUE WITH COMPONENT ENGAGEMENT OR ASSEMBLY.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 24071080 ↗InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). SHOULDER ID STUDY. INFECTION - DEEP. SUBJECT WAS FOUND TO HAVE GLENOID BASEPLATE LOOSENING AND INFECTION AT UNSCHEDULED 6-MONTH POST-OPERATIVE VISIT.
Patient problems: Unspecified Infection
MAUDE report 23665746 ↗InjuryNov 26, 2025Unstable; Unstable
SUBJECT: (B)(6) PERFORM FRACTURE STUDY. INSTABILITY ¿ DYNAMIC. SUBJECT CONTACTED CLINIC ON (B)(6) 2025 WITH REPORTS OF ATRAUMATIC INSTABILITY AND PAIN. SHE WAS SEEN IN CLINIC ON (B)(6) 2025. X-RAYS AND CT SCAN SHOWED MILD NOTCHING BUT NO OTHER ABNORMALITIES. NO DOCUMENTED DISLOCATIONS.
Patient problems: Joint Impingement; Pain
MAUDE report 23654534 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). PERFORM FRACTURE STUDY. TUBEROSITY MIGRATION (POST-OPERATIVE COMPLICATION). PER PI REVIEW OF XR ON (B)(6). 2025 "THERE WAS THINNING OF THE TUBEROSITY WITH SOME SLIGHT POSTERIOR DISPLACEMENT".
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 23602966 ↗InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT: (B)(6). SHOULDER ID STUDY. (B)(6) 2025. INSTABILITY, ANTERIOR DISLOCATION. PATIENT WAS FOUND TO HAVE A POST-OPERATIVE ANTERIOR SHOULDER DISLOCATION UPON X-RAY AT INITIAL POST-OPERATIVE VISIT. SHE WAS REVISED ON (B)(6) 2025.
Patient problems: Joint Dislocation
MAUDE report 23300189 ↗InjuryJul 21, 2025Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED FOLLOWING A PATIENT DISLOCATION. THE SURGEON DETERMINED A TALLER INSERT WAS REQUIRED TO ADDRESS THE INSTABILITY. DURING REMOVAL OF THE EXISTING INSERT, THE HUMERAL STEM BECAME LOOSE. CONSEQUENTLY, THE SURGEON ELECTED TO REVISE BOTH COMPONENTS, IMPLANTING LARGER PERFORM REVERSE SHOULDER IMPLANTS TO RESTORE STABILITY AND FIXATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 22560913 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: 12-008. PHS STEMLESS IDE STUDY. PARTICIPANT HAS BEEN EXPERIENCING PAIN, WITH NO KNOWN.
Patient problems: Pain
MAUDE report 22327653 ↗InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY WAS PLANNED USING THE BLUEPRINT PLANNING FEATURE. THIS WAS A REVISION SURGERY WITH TORNIER IMPLANTS, THE PATIENT WAS UNSTABLE AFTER THE ORIGINAL SURGERY. THE PATIENT IS A 76 YO FEMALE WHO SUFFERED A PROXIMAL HUMERUS FRACTURE WHERE THE SURGEON ORIGINALLY TREATED USING OUR PERFORM FRACTURE STEM. ON THE REVISION CASE THE SURGEON REMOVED THE ORIGINAL 36 MM STANDARD GLENOSPHERE AND 36 3/4 VITAMIN E 0MM POLY LINER. HE REPLACED THE SPHERE AND POLY WITH A 39 MM STANDARD GLENOSPHERE AND 39 3/4 0MM VE POLY FOR STABILITY. THE SURGERY WAS A SUCCESS AND THE PATIENT WAS REDUCED WITHOUT ANY FURTHER INSTABILITY ISSUES DUE TO UPSIZE IN THE SPHERE.
Patient problems: Joint Dislocation; Limb Fracture
MAUDE report 22074124 ↗
Other Tornier, Inc. products
- Tornier Perform Reversed Glenoid41 models · 515 reports · 1 recall
- Tornier Perform40 models · 290 reports · 1 recall
- TORNIER PERFORM HUMERAL SYSTEM68 models · 190 reports · 1 recall
- Tornier HRS40 models · 176 reports · 1 recall
- Tornier Perform Reversed Augmented Glenoid8 models · 121 reports · 1 recall
- AEQUALIS FLEX REVIVE24 models · 70 reports · 2 recalls
- Latitude - Elbow35 models · 147 reports
- Tornier Latitude7 models · 14 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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