MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET MV 40G - EO; BONE CEMENT : BONE CEMENT

Model Number 3122-040

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fibrosis (3167); No Code Available (3191)

Event Date 08/14/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Occupation: attorney.

Event Description

Patient was revised for findings of significant arthrofibrosis, loosening of the tibial base with dead bone found in the metaphysis-unknown loosening interface, and stretching/loosening of the lateral femoral condyle-unknown interface.The patella was not revised.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: SMARTSET MV 40G - EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8344184
• MDR Text Key: 136289935
• Report Number: 1818910-2019-84749
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: 10603295168379
• Combination Product (y/n): N
• PMA/PMN Number: K081155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 3122-040
• Device Catalogue Number: 3122040
• Device Lot Number: 8279986
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 03/27/2019; 08/24/2020
• Supplement Dates FDA Received: 04/04/2019; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR