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

Catalog Number	3122040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent a left tka due to arthritis.The patella was resurfaced and depuy cement x2 was used.There were no complications noted.On (b)(6) 2021, the patient underwent a revision of the left tka due to failed knee.The tibial component was noted to loose and was removed from the cement very easily.The femoral component, patella, and insert were also revised, but there were no allegations reported against those products.Competitor implants and cement were placed at revision.Doi: on (b)(6) 2016.Dor: on (b)(6) 2021.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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).Investigation summary: no device associated with this report was received for examination.According to the information received, ¿(b)(6) 2016: patient underwent a left tka due to arthritis.The patella was resurfaced and depuy cement x2 was used.There were no complications noted.(b)(6) 2021: patient underwent a revision of the left tka due to failed knee.The tibial component was noted to loose and was removed from the cement very easily.The femoral component, patella, and insert were also revised, but there were no allegations reported against those products.Competitor implants and cement were placed at revision." product code: 3122040.Lot: 8223862.Manufacturing date: 26 nov 2015.Expiry date: (b)(6) 2017.Quantity: 1324.Testing could not be completed as the retained samples are no longer available for testing.There were no non-conformances associated with this batch.All qc and microbiology testing met release specification (ms-037 smartset mv bone cement).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: product code: 3122040.Lot: 8223862.Manufacturing date: 26 nov 2015.Expiry date: (b)(6) 2017.Quantity: 1324.Device history review: there were no non-conformances associated with this batch.

• Brand Name: SMARTSET MV 40G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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 ; 3035526892
• MDR Report Key: 20672794
• Report Number: 1818910-2024-23608
• Device Sequence Number: 7238984
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: (01)10603295168379(17)171031(10)8223862
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• 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 Expiration Date: 10/31/2017
• Device Catalogue Number: 3122040
• Device Lot Number: 8223862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female