DJO SURGICAL
Received Jun 24, 2026 · Event occurred Jun 10, 2026
Report 1644408-2026-01241 · MDR key 25614454
Device
Generic name
Rsp Baseplate, 30mm, W/p2 Coating
Manufacturer
Encore Medical L.p.Catalog number
508-32-204
Lot number
769P3530
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
73 YR · Female
- Joint Laxity
Narrative
Additional Manufacturer Narrative
THE AGENT REPORTED A REVISION SURGERY DUE TO BASEPLATE LOOSENED. BASEPLATE, SCREWS, GLENOSPHERE AND HUMERAL POLY WERE EXPLANTED. PATIENT WAS IMPLANTED WITH HEMI ADAPTER AND HUMERAL HEAD. 72 YRS/MALE. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2019-00725; (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 PATIENT'S BASEPLATE WAS LOOSE.