InjuryKWS

DJO SURGICAL

Received Jul 20, 2026 · Event occurred Jun 25, 2026

Report 1644408-2026-01375 · MDR key 25883430

Device

Generic name

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

Manufacturer

Encore Medical L.p.

Catalog number

533-08-108

Lot number

926W1580

Product problems

Fracture

Patient

76 YR · Female

Bone Fracture(s)
Joint Laxity

Narrative

Description of Event or Problem

REVISION SURGERY - DUE TO CEMENTED STEM FROM ORIGINAL PROXIMAL HUMERAL FRACTURE LOOSENED.

Additional Manufacturer Narrative

COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-00647; 533-08-108, S810 - DEVICE LOOSENING, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.