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 Cyst(s) (1800); Pain (1994); No Code Available (3191)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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

Patient received a right primary attune to treat pain secondary to advanced osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right knee revision to treat pain secondary to loosening of the tibial tray.Upon entering the joint, the surgeon identified and excised a small cyst.The tibial tray was loosened and debonded at the cement to implant interface and removed.The femoral component was well-fixed but revised.The patella was well-fixed and retained.There was no reported product problem with the explanted tibial insert.The patient was revised with a depuy construct utilizing depuy cement.The procedure was completed without complications.Doi: (b)(6) 2015, dor: (b)(6) 2020, 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 at this time.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 29 may 2019.2 unrelated non-conformances on this lot number.Final micro and sterility tests passed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial report, a follow-up report 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: 10538117
• MDR Text Key: 207113404
• Report Number: 1818910-2020-20131
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8056343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 4 CEM; ATTUNE CR RP INSRT SZ4 7MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR