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

Catalog Number 545035500

Device Problem Device Slipped (1584)

Patient Problem Not Applicable (3189)

Event Date 04/25/2018

Event Type  Injury  

Event Description

Patient was revised to address tibial loosening at the cement to implant interface.Depuy cement manufacturer was used.Tibia was not grossly loose, but debonded from cement easily.Cement mantle to bone was intact.Doi: (b)(6) 2017; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint # : (b)(4).No device associated with this report was received for examination.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.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd.; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7536997
• MDR Text Key: 109012841
• Report Number: 1818910-2018-60336
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 545035500
• Device Lot Number: 8392998
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95