DEPUY CMW 2G 20G
Received Jul 31, 2026 · Event occurred Jul 13, 2026
Report 1818910-2026-13077 · MDR key 50097743
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
3325020
Lot number
5097140
Product problems
- Chemical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Cement immediately became hard when both components were brought together, there was not even a mixing, the cement was stored at room temperature, not in the refrigeratorReason why the product is not available: DiscardedHave patients or users been harmed? ## No ***Was there a significant delay? ## No ***If available, include the product order number (PO). ## LOT 5097140 ***
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.H11: Additional Manufacturer Narrative:If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.