MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 3092-040

Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revised to address failure due to aseptic loosening of the femur and tibial components.

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.Device history lot: device history reviewed on 03 jan 19.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.If information is obtained that was not available for the initial 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 synthese 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: device history reviewed on 03 jan 19.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.H10 additional narrative: corrected: the previous reported device code loose or intermittent connection is being corrected to loss of or failure to bond.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8102115
• MDR Text Key: 128287099
• Report Number: 1818910-2018-76288
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295168331
• UDI-Public: 10603295168331
• Combination Product (y/n): N
• PMA/PMN Number: K023012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 3092-040
• Device Catalogue Number: 3092040
• Device Lot Number: 7786762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 01/14/2019; 07/21/2020
• Supplement Dates FDA Received: 01/15/2019; 07/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR