MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3092040
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a piece of metal was found in the bone cement.
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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.Corrected: d3, g1.Recaptured code on h6 health effect: impact code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received, "it was reported that for item 3092040 lot # 4617337, since at the time of opening the bone cement, they have founded a metal piece on it." the product was returned to j&j medtech orthopaedics for evaluation.Additionally, all the available information and evidence was forwarded to the manufacturing site for further evaluation.Visual analysis found a metal piece inside the returned packaging of smartset hv bone cement 40g.It is worth noticing that the ampule, patient labels and an empty package of cement were retuned for evaluation.Based on the investigation performed by the manufacturer, the observed condition of the returned package was due to a rear guide detaching from a machine of the secondary packaging line.The overall complaint was confirmed as the observed condition of the smartset hv bone cement 40g would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: an nr was raised to address the reported complaint condition.Corrected: h3.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; fy4 4qq; suzhou industrial park; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22411507
• Report Number: 1818910-2025-11331
• Device Sequence Number: 9795176
• Product Code: LOD
• UDI-Device Identifier: 10603295168331
• UDI-Public: (01)10603295168331(17)261031(10)4617337
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 4617337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/13/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/23/2025; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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