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 03/04/2020

Event Type  Injury  

Manufacturer Narrative

(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 osteoarthritis.Intraoperatively, the surgeon identified medial compartment arthritic changes.The surgeon notes the patient has a history of tibial plateau fracture.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 tibial tray loosening.Upon entering the joint, the surgeon excised scar tissue and performed a complete synovectomy.The tibial tray was loosened at the cement to implant interface and easily removed.The femoral component and patella were well fixed and retained.There was no reported product problem with the explanted tibial insert.The patient received an attune revision tray and stem utilizing unknown cement.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2020.Right knee.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary.No device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot - device history reviewed (b)(6) 2020.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.(b)(4) units released.H10 additional narrative: added: g3.Corrected: d2b, d3, g5.

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.H10 additional narrative: dmf# - (b)(4).Trade name ¿ gentamicin sulphate; active ingredient(s) ¿ gentamicin sulphate; dosage form - powder; strength ¿ 1.0g active in our cements.Corrected: d2b and g5.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 IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10487990
• MDR Text Key: 205489609
• Report Number: 1818910-2020-19361
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 7807551
• 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 FB INSRT SZ 7 7MM.; ATTUNE CR FEM RT SZ 7 CEM.; ATTUNE FB TIB BASE SZ 7 CEM.; ATTUNE MEDIAL DOME PAT 41MM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; ATTUNE CR FB INSRT SZ 7 7MM; ATTUNE CR FEM RT SZ 7 CEM; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR