MAUDE Adverse Event Report: DePuy Ireland - 3015516266 SMARTSET; Bone Cement : Bone Cement

Catalog Number	3102080
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced aseptic tibial loosening.Tibia loosened at the cement/implant interface.All components were revised.Femur was not loose.No patient injury or delay.Doi: unknown.Dor: on (b)(6) 2026.Affected side: right knee.
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.Additional narrative: h3, h6: investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.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: a previous device history record (dhr) review ((b)(4)) was performed.The dhr review revealed of the (b)(4) unit batch, four unrelated non-conformances of this lot were identified.Final micro and sterility tests passed.

• Brand Name: SMARTSET
• 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 46581 ; +1(908)386-3534
• MDR Report Key: 50073333
• Report Number: 1818910-2026-12936
• Device Sequence Number: 10480455
• Product Code: LOD
• UDI-Device Identifier: 10603295168355
• UDI-Public: (01)10603295168355(17)161129(10)7786781
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K042591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2016
• Device Catalogue Number: 3102080
• Device Lot Number: 7786781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2014
• 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 PS FB INSRT SZ 4 6MM; ATTUNE PS FEM RT SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female