C-STEM
Received Jul 30, 2026 · Event occurred Jul 10, 2026
Report 1818910-2026-13073 · MDR key 50093434
Device
Generic name
Cement Centralizer/plug
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
961214500
Lot number
4685882
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
It was reported that the patient had infection and needed to have everything removed to place an antibiotic spacer.DOI: on (b)(6) 2026.DOR: on (b)(6) 2026.Affected side: Right hip.
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.