NA DRUJ-IS160Recalls & reported problems

Aptis Medical, LLC · Distal Radio-Ulnar Joint Stem, 1 cm Extended, 6.0 mm Diameter · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 B013DRUJIS1600), received between Jan 2, 2026 and Jan 2, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Installation-Related Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Installation-Related Problem1

Patient problems

Joint Dislocation1

Recent adverse event reports

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

InjuryJan 2, 2026Installation-Related Problem
WHILE REHABING HIS LEFT ARM PATIENT FELT THE DEVICE FAIL ON HIS RIGHT ARM WHILE PUSHING UP FROM A CHAIR.
Patient problems: Joint Dislocation
MAUDE report 23945920 ↗

Device details

UDI-DI	`B013DRUJIS1600`
Brand	NA
Model	DRUJ-IS160
Catalog no.	DRUJ-160
Company	Aptis Medical, LLC
Product code	KXE · Prosthesis, Wrist, Hemi-, Ulnar
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 6, 2021

Device type (GMDN): Wrist ulna-head prosthesis

A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Other Prosthesis, Wrist, Hemi-, Ulnar devices

NA DRUJ-IS145
Aptis Medical, LLC · Prosthesis, Wrist, Hemi-, Ulnar
1 report
NA DRUJ-LP10
Aptis Medical, LLC · Prosthesis, Wrist, Hemi-, Ulnar
1 report

All Prosthesis, Wrist, Hemi-, Ulnar devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
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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