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

Catalog Number	3122020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
On (b)(6) 2015, the patient underwent total left 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) 2018, the patient underwent a left knee revision due to loosening of the tibial component.The surgeon reported the tibial component was grossly loose at the implant to cement interface, and easily removed with just finger pressure.He noted the femoral component was stable and not revised.The patellar component was not revised.The patient was implanted with attune knee system and depuy cement x 2.There were no complications reported with the procedure.Doi: (b)(6) 2015.Dor: (b)(6) 2018, (lt knee).
Additional Manufacturer Narrative
This is a duplicate of 1818910-2018-71255.1818910-2019-119563 is being retracted as it is a report duplication.1818910-2018-71255 will be kept for investigational purposes.

• Brand Name: SMARTSET MV 20G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 9401677
• Report Number: 1818910-2019-119563
• Device Sequence Number: 16951817
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 07/30/2016
• Device Catalogue Number: 3122020
• Device Lot Number: 7936616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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 6MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE CR FB INSRT SZ 5 6MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE MEDIAL DOME PAT 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR