InjuryKWS

DJO SURGICAL

Received Jul 2, 2026 · Event occurred Jun 16, 2026

Report 1644408-2026-01281 · MDR key 25699915

Device

Generic name

Rsp, Primary Humeral Monoblock, 8mm X 108

Manufacturer

Encore Medical L.p.

Catalog number

510-00-008

Lot number

979F1074

Product problems

Loosening of Implant Not Related to Bone-Ingrowth

Patient

83 YR · Female

Joint Laxity

Narrative

Description of Event or Problem

REVISION SURGERY - DUE TO LOOSE STEM THAT BROKE THROUGH CEMENT MANTLE. HUMERAL BONE LOSS.

Additional Manufacturer Narrative

COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2026-01281; 510-00-006, S810 - DEVICE LOOSENING, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.