inforMED
InjuryKWS

DJO SURGICAL

Received Jun 29, 2026 · Event occurred Jun 12, 2026

Report 1644408-2026-01260 · MDR key 25649082

Device

Generic name

Rsp Humeral Socket Insert, 36mm +4mm, Standard Hxe-plus

Manufacturer

Encore Medical L.p

Catalog number

509-00-436

Lot number

386P1419

Product problems

  • Unstable

Patient

56 YR · Male

  • Joint Laxity

Narrative

Description of Event or Problem

REVISION SURGERY DUE TO INSTABILITY.

Additional Manufacturer Narrative

THE AGENT REPORTED, PATIENT WAS UNSTABLE. DOCTOR REMOVED GLENOID AND POLY. PUT IN 40MM +8 GLENOID, 8 SPACER AND 40MM +4 SEMI-CONSTRAINED POLY. 56 YR OLD MALE. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2019-01037; S814 - STABILITY, POOR JOINT, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.