MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number	545050501
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had aseptic tibial loosening.Tibial tray debonded at the cement/tray interface.Femur wasn't loose.The tibia and femur were both revised.No patient injury or delay.No more info known.Product stated to be loose: tibia.Loosening interface: cement to implant.Cement manufacturer: depuy.Doi: (b)(6) 2012.Dor: (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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.G4: "dmf# - (b)(4) trade name ¿ gentamicin sulphate active ingredient(s) ¿ gentamicin sulphate dosage form - powder strength ¿ 1.0g active in our cements." 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).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Added: d1, d10 (concomitant).

• Brand Name: SMARTSET GMV 40G US EO
• 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25085012
• Report Number: 1818910-2026-08230
• Device Sequence Number: 10473281
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: (01)10603295174295
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 545050501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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: SIG MOD TIB TRAY CEM COCR 3; SIGMA PS CEM FEM SZ4 R; SIGMA STAB GVF INS 3 12.5MM; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male