InjuryKWS

DJO SURGICAL

Received Jun 24, 2026 · Event occurred Jun 10, 2026

Report 1644408-2026-01248 · MDR key 25614455

Device

Generic name

Altivate Reverse, Humeral Stem, Small Shell, Sz 8x108mm

Manufacturer

Encore Medical L.p.

Catalog number

533-08-108

Lot number

926W2328D

Product problems

Loosening of Implant Not Related to Bone-Ingrowth

Patient

72 YR · Female

Joint Laxity

Narrative

Additional Manufacturer Narrative

THE AGENT REPORTED A REVISION SURGERY DUE TO STEM CAME LOOSE, WENT UP A SIZE, AND CEMENTED THE NEW STEM. FEMALE 72. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-01681; (B)(4), S810 - DEVICE LOOSENING, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

Description of Event or Problem

REVISION SURGERY - DUE TO STEM CAME LOOSE.