DELTA XTEND
Received Jul 30, 2026 · Event occurred Jul 10, 2026
Report 1818910-2026-13059 · MDR key 50091045
Device
Generic name
Delta Xtend Implants : Shoulder Humeral Stems
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
130710000
Lot number
4982268
Product problems
- Loss of or Failure to Bond
Patient
68 YR · Female
- Loss of Range of Motion
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT #(b)(4).This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial MedWatch, a Follow-up MedWatch will be filed as appropriate.
Description of Event or Problem
It was reported that patient had limited range of motion. Upon revision, the stem was found to be loose in its cement mantle. All components but the metaglene and screws were revised. It was stated that humeral stem was loose. Loosening interface was marked as cement to implant. Cement manufacturer was marked as DePuy Synthes. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right shoulder.