Tornier Perform DWM003ARecalls & reported problems

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832092192), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 injury.

1 FDA recall record name this device's 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, 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.

Recalls naming this device

Aug 29, 2024Open, Classified
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Z-3155-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Hematoma1

Recent adverse event reports

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

InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) PERFORM HUMERAL SYSTEM STUDY (PHS). HEMATOMA: SUBJECT EXPERIENCED A HEMATOMA WITH DRAINAGE.
Patient problems: Hematoma
MAUDE report 23654374 ↗

Device details

UDI-DI	`00846832092192`
Brand	Tornier Perform
Model	DWM003A
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.