PERFORM™ HUMERAL SYSTEM DWS1360Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832077991), received between Apr 24, 2023 and Aug 24, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Unstable1
Patient problems
- Bone Fracture(s)2
- Joint Dislocation2
- Joint Laxity1
- Limb Fracture1
- Loss of Range of Motion1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) SHOULDER ID STUDY. SCAPULAR FRACTURE - SCAPULAR SPINE (POST-OPERATIVE)".
Patient problems: Bone Fracture(s)
MAUDE report 21147060 ↗InjuryMay 17, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD SUBJECTIVE INSTABILITY. PATIENT STATES FEELING THAT THE SHOULDER "POP OUT" AND HAS TO WAIT FOR IT TO POP BACK IN TO RESUME ACTIVITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 16950446 ↗InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT 01-013 DEVELOPED AN ACROMIAL FRACTURE. THE PATIENT WILL BE UNDERGOING NONOPERATIVE TREATMENT AND WILL BE IMMOBILIZED IN A SLING. PATIENT WILL FOLLOW UP IN 6 WEEKS.
Patient problems: Bone Fracture(s); Limb Fracture; Loss of Range of Motion
MAUDE report 16800547 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.