DJO SURGICAL
Received May 4, 2026 · Event occurred Apr 9, 2026
Report 1644408-2026-00803 · MDR key 25074798
Device
Generic name
Altivate Reverse, Humeral Stem, Standard Shell, Sz 12x108mm
Manufacturer
Encore Medical L.p.Catalog number
530-12-108
Lot number
412T1984D
Product problems
- Device Dislodged or Dislocated
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
74 YR · Male
- Joint Dislocation
- Joint Laxity
Narrative
Additional Manufacturer Narrative
REVISION SURGERY DUE TO PATIENT WAS DISLOCATED. REVISION SURGERY WAS SCHEDULED. WHILE ATTEMPTING TO REMOVE POLY, THE STEM WAS DEEMED LOOSE AND THUS REMOVED. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2018-00844; 530-10-108, S810 - DEVICE LOOSENING, S803 - DISLOCATION, 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 WAS DISLOCATED. REVISION SURGERY WAS SCHEDULED. WHILE ATTEMPTING TO REMOVE POLY, THE STEM WAS DEEMED LOOSE AND THUS REMOVED.