MAUDE Adverse Event Report: DePuy Ireland - 3015516266 DEPUY CMW 1 40G; Bone Cement : Bone Cement

Catalog Number	3312040
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during arthroplasty, mixing of the two cement components resulted in a non-homogeneous mass unsuitable for implantation.Therefore, an alternative cement was used, resulting in a 15-minute surgical delay.
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.

• Brand Name: DEPUY CMW 1 40G
• Common Device Name: Bone Cement : Bone Cement
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CMW Mfg & Material Warehouse; UK
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN ; +1(908)386-3534
• MDR Report Key: 50852065
• Report Number: 1818910-2026-16337
• Device Sequence Number: 21245579
• Product Code: LOD
• UDI-Device Identifier: 10603295168614
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K053003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3312040
• Device Lot Number: 5054125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown