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

Catalog Number	3122040
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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.4.
Event or Problem Description
It was reported that the depuy smartest mv did not mix as usual, was ¿sticky¿ and started to set up early.Surgeon did not like the consistency and was afraid wouldn¿t get in implants seated.A tibial tray was wasted because it was coated with cement and could not be removed properly before hardening.A second batch of two 40g smartset with the identical lot numbers was mixed without incident.Surgical time was increased 5 minutes to open new products.Affected area: right knee.
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 that 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:b5, h6 health effect ( clinical and impact code).If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that: was/were there any adverse consequence/s that affected the patient because of the reported event? patient outcome was not affected as the doctor noticed the issue and requested a new batch of cement and a new tibia baseplate.
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 the depuy smartest mv did not mix as usual, was ¿sticky¿ and started to set up early.Surgeon did not like the consistency and was afraid wouldn¿t get in implants seated.A tibial tray was wasted because it was coated with cement and could not be removed properly before hardening.A second batch of two 40g smartset with the identical lot numbers was mixed without incident.Surgical time was increased 5 minutes to open new products." product name: smartset mv 40g - eo, product code: 3122040, lot: 4591843, manufacturing date: 18 sep 24, expiry date: 31 aug 26, quantity: (b)(4).There is one non-conformance associated with this lot.On review of the applicable nc it has been identified that the nc would not have contributed to the complaint event.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 review: product name: smartset mv 40g - eo, product code: 3122040, lot: 4591843, manufacturing date: 18 sep 24, expiry date: 31 aug 26, quantity: (b)(4).There is one non-conformance associated with this lot.On review of the applicable nc it has been identified that the nc would not have contributed to the complaint event.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22009793
• Report Number: 1818910-2025-07717
• Device Sequence Number: 20172269
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: (01)10603295168379(17)260831(10)4591843
• 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
• 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 Expiration Date: 08/31/2026
• Device Catalogue Number: 3122040
• Device Lot Number: 4591843
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/27/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/19/2025; 05/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE RP TIB BASE SZ 4 CEM.; SMARTSET MV 40G - EO.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 105 KG