MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET MV 20G - EO; BONE CEMENT : BONE CEMENT

Model Number	3122-020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Complaint description: der stated that the patient has 59 bmi, took out a size 5 cr attune femur, size 3 fixed bearing tibia.Don't have access to any other information or lot numbers.On (b)(6) 2015, the patient underwent total right knee arthroplasty due to degenerative joint disease.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2017, the patient underwent a right knee revision due to loosening of the tibial component.The surgeon reported the tibial component was grossly loose and elevated with a simple osteotome with minimal difficulty.He reported no concerns regarding the femoral component, and it was revised.The surgeon did no comment on the patella, and it was not revised.The patient was implanted with depuy knee system.Competitor¿s cement was utilized, and there were no complications reported.Doi: (b)(6) 2015.Dor: (b)(6) 2017.(rt 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 which 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.Patient code: no code available (3191) is used to capture device revision or replacement and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : device history reviewed: 7927857 1 unrelated non-conformance on this lot number final micro and sterility tests passed all qc release specifications met (b)(4) units released.

• Brand Name: SMARTSET MV 20G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 9474289
• Report Number: 1818910-2019-123152
• Device Sequence Number: 2659932
• Product Code: LOD
• UDI-Device Identifier: 10603295168362
• UDI-Public: 10603295168362
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2017

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: 05/31/2016
• Device Model Number: 3122-020
• Device Catalogue Number: 3122020
• Device Lot Number: 7927857
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 10/30/2020; 05/13/2021
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 11/13/2020; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FB INSRT SZ 5 5MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 32MM; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR