InjuryOIY

DJO SURGICAL

Received Jun 18, 2026 · Event occurred Jun 2, 2026

Report 1644408-2026-01193 · MDR key 25553166

Device

Generic name

Insert, 3d Ex Sz 4lt 9mm

Manufacturer

Encore Medical L.p.

Catalog number

391-09-704

Lot number

281G1965

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

71 YR · Female

Unspecified Infection

Narrative

Additional Manufacturer Narrative

THE AGENT REPORTED REVISION FOR INFECTION. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2019-00823; 391-09-704, S808 - INFECTION, 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 GROSSLY INFECTED REQUIRING REMOVAL OF COMPONENTS & PLACEMENT OF SPACER. FEMALE 71.