MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET MV 40G - EO; BONE CEMENT : BONE CEMENT

Catalog Number	3122040
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that cement box did not contain a patient label.The box label and package labels matched.Product was used.There was no delay or harm to patient.Doe: (b)(6) 2024 affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Lot: 4282471, manufacturing date: 02 oct 23, expiry date: 30 sep 25, quantity: (b)(4).Product checked: retained samples.Required testing: tm-t150 cement setting time.There are no non-conformances associated with this lot.The samples returned were tested in a temperature and humidity-controlled laboratory.Lot: 4282471, dough time: 3 min 02s (spec: 5 min 00s max), mix characteristics: soft, setting time: 11 min 42s (spec: 09 min 00s to 13 min 30s).The cement mixed and behaved as expected for the product type and met the appropriate control specification.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 : lot: 4282471 manufacturing date: 02 oct 23 expiry date: 30 sep 25 quantity: (b)(4).Device history review : there are no non-conformances associated with this lot.The samples returned were tested in a temperature and humidity-controlled laboratory.

• Brand Name: SMARTSET MV 40G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19583246
• Report Number: 1818910-2024-13534
• Device Sequence Number: 3530103
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: (01)10603295168379(10)4282471(17)250930
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/21/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 3122040
• Device Lot Number: 4282471
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2020
• 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 Age: 61 YR
• Patient Sex: Male