Tornier Perform DWM001ARecalls & reported problems

Tornier, Inc. · US Anatomic Nucleus · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832092178), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 injury.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Implant Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). PERFORM HUMERAL SYSTEM STUDY (PHS). UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY. SUBJECT CONTACTED SURGEON'S OFFICE WITH COMPLAINTS OF PAIN. SUBJECT COMPLETED A COURSE OF PHYSICAL THERAPY AND UNDERWENT AN ULTRASOUND WHICH SHOWED MILD BURSITIS. SUBJECT WAS STILL EXPERIENCING PAIN AT TWO-YEAR POST-OP VISIT AND RECEIVED A STEROID INJECTION.
Patient problems: Implant Pain
MAUDE report 23642301 ↗

Device details

UDI-DI	`00846832092178`
Brand	Tornier Perform
Model	DWM001A
Company	Tornier, Inc.
Product code	PKC · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Oct 3, 2022

Device type (GMDN): Trabeculated shoulder humeral stem prosthesis

A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and has a convoluted/perforated surface intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is typically intended to be performed without bone cement.

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All Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.