inforMED
InjuryHSD

DELTA XTEND

Received Jul 27, 2026 · Event occurred Aug 23, 2024

Report 1818910-2026-12555 · MDR key 50003986

Device

Generic name

Delta Xtend Implants : Screws

Catalog number

130770024

Lot number

5370169

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Male

  • Unspecified Infection
  • Pain

Narrative

Description of Event or Problem

It was reported that on (b)(6) 2024, the patient had a Primary Delta Xtend Reverse. On (b)(6) 2024, patient had their implants removed due to infection and pain and a spacer was placed for treatment of infection. On (b)(6) 2024, the patient had their first spacer removed and a second spacer placed for continued treatment of infection. On (b)(6) 2025, the second spacer was removed and final implants were placed.This complaint is related to (b)(4) which captures reported additional events.

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.