MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 Description

Patient received a right primary attune to treat pain secondary to degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right tka revision to treat pain secondary to loosening.Upon entering the joint, the surgeon and excised scar tissue.The tibial tray was loosened and debonded at the cement to implant interface.The patella was well-fixed but revised to accommodate the new components.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patient was implanted with competitor products.The procedure was completed without complications.Doi: (b)(6) 2017, doi: (b)(6) 2019, right knee.

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.

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.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10333640
• MDR Text Key: 200652418
• Report Number: 1818910-2020-17001
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• 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: 07/16/2020

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: 03/31/2019
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8525085
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 09/02/2020
• Supplement Dates FDA Received: 09/02/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE MEDIAL ANAT PAT 32 MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 8 MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR