GLOBAL UNITE
Received Jul 27, 2026 · Event occurred Aug 23, 2024
Report 1818910-2026-12559 · MDR key 50004143
Device
Generic name
Global Unite Implants : Shoulder Humeral Stems
Manufacturer
Finsbury Orthopaedics LimitedCatalog number
110010100
Lot number
4374296
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- 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) and (b)(4) which captures reported additional events.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # ==> PC-002207928This 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.