InjuryJWI

UNIVERSAL 2

Received Sep 11, 2018 · Event occurred Nov 1, 2017

Report MW5079719 · MDR key 7868796

Device

Generic name

Universal Total Wrist System

Manufacturer

Integra Lifesciences Corporation

Model number

26-3100R, 26-2101

Lot number

077132, 077127

Product problems

Protective Measures Problem

Patient

68 YR

Rupture
Patient Problem/Medical Problem
Rupture
Patient Problem/Medical Problem

Narrative

Description of Event or Problem

WRIST IMPLANT FAILURE CAUSING HEAVY METALLOSIS, AND PRODUCT FAILURE CAUSING RUPTURED FINGER TENDONS. METAL ON METAL FROM UNIVERSAL 2 IMPLANTED IN 2008, REMOVED IN 2018. COMPANY: INTEGRA LIFESCIENCES.