GLOBAL UNITE

Additional Manufacturer Narrative

PRODUCT COMPLAINT # ==> PC-002204162This 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. Additional Narrative:D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available.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 Primary reverse Delta Xtend on (b)(6) 2024.Patient underwent the removal of infected reverse shoulder arthroplasty.The patient has an extensive history of implant removals and reimplantations secondary to recurrent infections, pain, including Staphylococcus species and Cutibacterium acnes. Additional reported cases are captured as follows:(b)(6) 2024 -Removal due to Infection / pain (captured under (b)(4)).(b)(6) 2024 -Removal due to Infection / pain (Captured under related (b)(4)).(b)(6) 2025-Revision Central Screw Metaglene , 145 Epiphysis (Captured under related (b)(4)).(b)(6) 2025- Infection and severe pain, revision wash out only and pathology done, no implant change (Captured under related (b)(4) and (b)(4)).This report captures: (b)(6) 2026 Removal planned as still infected, no CT done.