TORNIER PERFORM HUMERAL SYSTEMRecalls & reported problems across all models

We found 68 models of TORNIER PERFORM HUMERAL SYSTEM by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2021 and Sep 28, 2026 — classified as 1 death, 170 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (48 reports).

1 FDA recall record name at least one of these models by its device 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. 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

TORNIER PERFORM HUMERAL SYSTEM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 TORNIER PERFORM HUMERAL SYSTEM problems

TORNIER PERFORM HUMERAL SYSTEM models

68 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TORNIER PERFORM™ HUMERAL SYSTEM DWP2393

  shoulder prosthesis, reverse configuration
  1 recall2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX3SS

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  14 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX2PS

  prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
  12 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP1360

  shoulder prosthesis, reverse configuration
  10 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX3PS

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  10 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2390

  shoulder prosthesis, reverse configuration
  9 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2360

  shoulder prosthesis, reverse configuration
  6 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX934

  shoulder prosthesis, reverse configuration
  6 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWR4426

  shoulder prosthesis, reverse configuration
  5 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWT110

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX2SS

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  5 reports
• Tornier Perform Humeral System ARS1022306

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWN4316

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  4 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2363

  shoulder prosthesis, reverse configuration
  4 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2420

  shoulder prosthesis, reverse configuration
  4 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWR2390

  shoulder prosthesis, reverse configuration
  4 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWT100

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  4 reports
• TORNIER PERFORM™ HUMERAL SYSTEM MWM035

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP1393

  shoulder prosthesis, reverse configuration
  3 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP4393

  shoulder prosthesis, reverse configuration
  3 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX1PL

  prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
  3 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX4PS

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 death3 reports
• Tornier Perform Humeral System PFX08130S

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• Tornier Perform Humeral System PFX09130

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• TORNIER PERFORM™ HUMERAL SYSTEM MWX135

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWN4115

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWN5019

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP1363

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP1366

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP1390

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2396

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2423

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP3390

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWP4396

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWR4420

  shoulder prosthesis, reverse configuration
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX1SS

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX2PL

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX4PL

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM DWX4SS

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• Tornier Perform Humeral System PFX10130

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• TORNIER PERFORM™ HUMERAL SYSTEM MWX4SS

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM MWM001

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWN4314

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWN4816

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWN4818

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWP1396

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2366

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWP2426

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWP3360

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWP4390

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWP4426

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR1363

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR1390

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR1393

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR1396

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR2420

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR2426

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR3360

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWR4393

  shoulder prosthesis, reverse configuration
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWT4617

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• TORNIER PERFORM™ HUMERAL SYSTEM DWX3PL

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier Perform Humeral System IFX801

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier Perform Humeral System PFX09130S

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• Tornier Perform Humeral System PFX11130

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• Tornier Perform Humeral System PFX14130

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier Perform Humeral System PFX15130

  shoulder prosthesis, reverse configuration
  1 report
• Tornier Perform Humeral System PFX00120

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier Perform Humeral System ARS1023803

  TEMPLATE
  1 report

Recent TORNIER 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 28, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 50922232 ↗
• InjurySep 28, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50922228 ↗
• MalfunctionSep 1, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540926 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  All implants were removed due to suspected infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50042216 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SUSPECTED INFECTION. DURING THE PROCEDURE, THE IMPLANT WAS CLEANED, AND THE INSERT WAS REMOVED AND REPLACED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25736201 ↗
• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE INSTRUMENT'S PEGS BROKE. NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579190 ↗
• InjuryJun 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT SUSTAINED A PROXIMAL HUMERUS FRACTURE THAT WAS TREATED WITH TUBEROSITY REPAIR AND HEMIARTHROPLASTY. AT THE TIME OF THE PROCEDURE, THE ROTATOR CUFF WAS CONFIRMED TO BE INTACT. FOLLOWING SURGERY, THE PATIENT WAS REPORTEDLY NON-COMPLIANT WITH SLING USE AND NON-WEIGHT-BEARING RESTRICTIONS, RESULTING IN FAILURE OF THE FRACTURE REPAIR. THE PATIENT DID NOT RETURN FOR FOLLOW-UP UNTIL A LATER DATE, AT WHICH TIME CONCERNS REGARDING THE OUTCOME OF THE REPAIR WERE IDENTIFIED. FOLLOWING POSITIVE CULTURE RESULTS, THE PATIENT REQUESTED REMOVAL OF THE HEMIARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE SURGEON EXPLAINED THE ANTICIPATED FUNCTIONAL LIMITATIONS ASSOCIATED WITH REMOVAL OF THE IMPLANT; HOWEVER, THE PATIENT ELECTED TO PROCEED WITH EXPLANTATION. THE HEMIARTHROPLASTY WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.

  Patient problems: Loss of Range of Motion; Post Operative Wound Infection

  MAUDE report 25563777 ↗
• InjuryJun 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT SUSTAINED A PROXIMAL HUMERUS FRACTURE THAT WAS TREATED WITH TUBEROSITY REPAIR AND HEMIARTHROPLASTY. AT THE TIME OF THE PROCEDURE, THE ROTATOR CUFF WAS CONFIRMED TO BE INTACT. FOLLOWING SURGERY, THE PATIENT WAS REPORTEDLY NON-COMPLIANT WITH SLING USE AND NON-WEIGHT-BEARING RESTRICTIONS, RESULTING IN FAILURE OF THE FRACTURE REPAIR. THE PATIENT DID NOT RETURN FOR FOLLOW-UP UNTIL A LATER DATE, AT WHICH TIME CONCERNS REGARDING THE OUTCOME OF THE REPAIR WERE IDENTIFIED. FOLLOWING POSITIVE CULTURE RESULTS, THE PATIENT REQUESTED REMOVAL OF THE HEMIARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE SURGEON EXPLAINED THE ANTICIPATED FUNCTIONAL LIMITATIONS ASSOCIATED WITH REMOVAL OF THE IMPLANT; HOWEVER, THE PATIENT ELECTED TO PROCEED WITH EXPLANTATION. THE HEMIARTHROPLASTY WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.

  Patient problems: Loss of Range of Motion; Post Operative Wound Infection

  MAUDE report 25563263 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "BECAUSE THE PATIENT WAS EXPERIENCING PAIN, A REVISION SURGERY WAS PERFORMED TO DETERMINE IF THE IMPLANT WAS LOOSE OR NEEDED RESIZING. A SLIGHT FOREIGN BODY REACTION SUGGESTIVE OF INFECTION WAS OBSERVED."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25337042 ↗
• InjuryMay 19, 2026Device Dislodged or Dislocated

  THE PROCEDURE TOOK PLACE DUE TO CHRONIC DISLOCATION. ONCE THE SURGEON GOT EXPOSURE, THE TRAY AND POLY WERE REMOVED AND THE POLY HAD MEDIAL WEAR.

  Patient problems: Insufficient Information

  MAUDE report 25217218 ↗
• MalfunctionMay 6, 2026Fracture

  IT WAS REPORTED THAT LATERALITY IS MISSING FROM HANDLE. THE LOCKING MECHANISM IS BROKEN. THE PHYSICIAN ATTEMPTED TO FIX IT BUT IT DIDN'T WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101773 ↗
• MalfunctionMay 1, 2026Fracture

  DURING USE, THE SLAPHAMMER FRACTURED WHILE ENGAGED WITH A SIZE 4 TRIAL STEM. ADDITIONALLY, TWO SIZE 2 SIZER DISCS WERE NOTED TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059572 ↗
• InjuryApr 28, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A PLANNED RIGHT REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2026. POST OPERATIVE DAY ONE, ROUTINE X RAY IMAGING IDENTIFIED A DISLOCATION OF THE GLENO HUMERAL JOINT REPLACEMENT, WITH ANTERIOR SUBLUXATION OF THE PROXIMAL HUMERUS. IMAGING ALSO DEMONSTRATED THAT THE METALLIC RING COMPONENT OF THE PROSTHESIS HAD DISSOCIATED FROM THE IMPLANT. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THESE COMPONENTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Subluxation

  MAUDE report 25016119 ↗
• MalfunctionApr 15, 2026Fracture

  A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN HUMERAL STEM WHICH WAS BROKEN AT THE END LEVEL OF THE SUPERIOR MOST LATERAL SCREW.

  Patient problems: Insufficient Information

  MAUDE report 24888828 ↗
• MalfunctionApr 7, 2026Material Erosion

  IT WAS REPORTED THAT, WHEN INSERTING THE GUIDE PIN (3X75 MM) INTO THE IM CUTTING BLOCK 135° (MWX135), METAL ABRASION OCCURRED ON THE GUIDE PIN AT THE UPPER 0° HOLE FOR THE GUIDE PINS FOR RESECTION OF THE RIGHT SHOULDER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801419 ↗

Other Tornier, Inc. products

• Tornier Perform Reversed Glenoid41 models · 515 reports · 1 recall
• Tornier Perform40 models · 290 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
• Latitude EV24 models · 56 reports