MAUDE Adverse Event Report: DEPUY IRELAND SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3092040
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that when opening the cement package, the packaging with powder had a hole and, it was spilling into the sealed packaging around it.It was caught before, not used and still sealed.Doi: (b)(6) 2025.Dor: (b)(6) 2025.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.According to the information received, ¿it was reported that when opening the cement package, the packaging with powder had a hole and was spilling into the sealed packaging around it.It was caught before, not used and still sealed.¿ product name: smartset hv bone cement 40g.Product code: 3092040.Lot number: 4625049.Manufacturing date: 2025-02-24.Expiry date: 2027-01-31.Quantity: (b)(4).There was 1 non-conformance on this lot.On review of the applicable ncs none have been identified which would contribute to the complaint event.All qc and microbiology testing met specification.A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > product name: smartset hv bone cement 40g.Product code: 3092040.Lot number: 4625049.Manufacturing date: 2025-02-24.Expiry date: 2027-01-31.Quantity: (b)(4).A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.Device history review = > there was 1 non-conformance on this lot.On review of the applicable ncs none have been identified which would contribute to the complaint event.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23512256
• Report Number: 1818910-2025-19443
• Device Sequence Number: 9733290
• Product Code: LOD
• UDI-Device Identifier: 10603295168331
• UDI-Public: (01)10603295168331(17)270131(10)4625049
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 3092040
• Device Lot Number: 4625049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown